Paracervical local anaesthesia for cervical dilatation and uterine intervention

  • Conclusions changed
  • Review
  • Intervention

Authors


Abstract

Background

Cervical dilatation and uterine intervention can be performed under sedation, local or general anaesthesia for obstetrics and gynaecological conditions. Many gynaecologists use paracervical local anaesthesia but its effectiveness is unclear. This review was originally published in 2009 and was updated in 2013.

Objectives

The objectives of this review were to determine the effectiveness and safety of paracervical local anaesthesia for cervical dilatation and uterine intervention, versus no treatment, placebo, other methods of regional anaesthesia, sedation and systemic analgesia, and general anaesthesia.

Search methods

We reran our search to August 2013. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to August 2013), EMBASE (1980 to August 2013), and reference lists of articles. The original search was performed in January 2006.

Selection criteria

We included randomized or controlled clinical studies involving women who underwent cervical dilatation and uterine intervention for obstetrics and gynaecological conditions. We included studies which compared paracervical anaesthesia with no treatment, placebo, other methods of regional anaesthesia, systemic sedation and analgesia, or general anaesthesia.

Data collection and analysis

Two authors independently evaluated the studies, extracted data, and checked and entered data into Review Manager.

Main results

This updated review includes nine new studies, in total 26 studies with 28 comparisons and involving 2790 participants. No study of local paracervical versus general anaesthesia met our criteria. Ten studies compared local anaesthetic versus placebo. Paracervical local anaesthetic (PLA) reduced pain on cervical dilatation with a standardized mean difference (SMD) of 0.37 (95% CI 0.17 to 0.58) and a relative risk (RR) of severe pain of 0.16 (95% CI 0.06 to 0.74). PLA also reduced abdominal pain during, but not after, uterine intervention (SMD 0.74, 95% CI 0.28 to 1.19); there was no evidence of any effect on postoperative back or shoulder pain. Comparisons against no treatment did not demonstrate any effect of PLA. Five studies compared paracervical block with uterosacral block, intracervical block, or intrauterine topical anaesthesia. Two of these studies showed no significant difference in pain during the procedure. Compared to intrauterine instillation, PLA slightly reduced severe pain (from 8.3 to 7.6 on a 10-point scale), which may be negligible. Six studies compared PLA with sedation. There were no statistically significant differences in pain during or after the procedure, postoperative analgesia requirement, adverse effects, patient satisfaction, and the operator's perception of analgesia. We performed risk of bias assessment using six domains and found that more than half of the included studies had low risk of bias.

Authors' conclusions

We found that no technique provided reliable pain control in the 26 included studies. Some studies reported that women experienced severe pain (mean scores of 7 to 9 out of 10) during uterine intervention, irrespective of the analgesic technique used. We concluded that the available evidence fails to show whether paracervical block is inferior, equivalent, or superior to alternative analgesic techniques in terms of efficacy and safety for women undergoing cervical dilatation and uterine interventions. We suggest that woman are likely to consider the rates and severity of pain during uterine interventions when performed awake to be unacceptable in the absence of neuraxial blockade, which are unaltered by paracervical block.

Resumen

Anestesia local paracervical para la dilatación cervical y la intervención uterina

Antecedentes

La dilatación cervical y la intervención uterina se pueden realizar bajo sedación, anestesia local o general en afecciones obstétricas y ginecológicas. Muchos ginecólogos utilizan la anestesia local paracervical aunque su efectividad es incierta. Esta revisión fue publicada originalmente en 2009 y se actualizó en 2013.

Objetivos

Los objetivos de esta revisión eran determinar la efectividad y la seguridad de la anestesia local paracervical para la dilatación cervical y la intervención uterina versus ningún tratamiento, placebo, otros métodos de anestesia regional, sedación y analgesia sistémica y anestesia general.

Métodos de búsqueda

La búsqueda se volvió a ejecutar en agosto de 2013. Se hicieron búsquedas en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL) (The Cochrane Library 2013, número 8), MEDLINE (1966 hasta agosto de 2013), EMBASE (1980 hasta agosto de 2013), y en listas de referencias de artículos. La búsqueda original se realizó en enero de 2006.

Criterios de selección

Se incluyeron estudios clínicos aleatorios o controlados que reclutaron pacientes a las que se les realizó dilatación cervical e intervención uterina por afecciones obstétricas y ginecológicas. Se incluyeron los estudios que compararon anestesia paracervical con ningún tratamiento, placebo, otros métodos de anestesia regional, sedación sistémica y analgesia, o anestesia general.

Obtención y análisis de los datos

Dos revisores, de forma independiente, evaluaron los estudios, extrajeron los datos y los verificaron e introdujeron en Review Manager.

Resultados principales

Esta revisión actualizada incluye nueve nuevos estudios, con un total de 26 estudios con 28 comparaciones que implican a 2790 participantes. Ningún estudio de anestesia local paracervical versus anestesia general cumplió los criterios. Diez estudios compararon anestésico local versus placebo. El anestésico local paracervical (ALP) redujo el dolor en la dilatación cervical con una diferencia de medias estandarizada (DME) de 0,37 (IC del 95%: 0,17 a 0,58) y un riesgo relativo (RR) de dolor intenso de 0,16 (IC del 95%: 0,06 a 0,74). El ALP también redujo el dolor abdominal durante, pero no después de, la intervención uterina (DME 0,74; IC del 95%: 0,28 a 1,19); no hubo pruebas de cualquier efecto sobre el dolor posoperatorio lumbar o del hombro. Las comparaciones contra ningún tratamiento no demostraron cualquier efecto del ALP. Cinco estudios compararon bloqueo paracervical con bloqueo uterosacro, bloqueo intracervical, o anestesia intrauterina tópica. Dos de tres estudios no mostraron diferencias significativas en el dolor durante el procedimiento. Comparada con la instilación intrauterina, el ALP redujo levemente el dolor intenso (de 8,3 a 7,6; en una escala de 10 puntos), que puede ser insignificante. Seis estudios compararon ALP con sedación. No hubo diferencias estadísticamente significativas en el dolor durante o después del procedimiento, la necesidad de analgesia posoperatoria, los efectos adversos, la satisfacción de la paciente y la percepción del operador de la analgesia. Para la evaluación del riesgo de sesgo se utilizaron seis dominios y se encontró que más de la mitad de los estudios incluidos tuvo bajo riesgo de sesgo.

Conclusiones de los autores

Ninguna técnica proporcionó un control del dolor confiable en los 26 estudios incluidos. Algunos estudios informaron que las pacientes presentaron dolor intenso (puntuaciones medias de 7 a 9 de 10) durante la intervención uterina, independientemente de la técnica analgésica utilizada. Se concluyó que las pruebas disponibles no logran mostrar si el bloqueo paracervical es inferior, equivalente o superior a las técnicas analgésicas alternativas en cuanto a la eficacia y la seguridad, para las pacientes a las que se les realizan intervenciones uterinas. Se indica que es probable que la paciente considere que las calificaciones y la gravedad del dolor durante las intervenciones uterinas, cuando se realizan estando despierta, son inadmisibles cuando no hay bloqueo neuroaxial, el cual no es modificado por el bloqueo paracervical.

Plain language summary

Paracervical local anaesthesia for cervical dilatation and uterine interventions

Paracervical block involves injection of local anaesthetic around the cervix to numb nearby nerves. Cervical dilatation and uterine interventions (such as hysteroscopy, endometrial biopsies, fractional curettage, and suction terminations) can be performed without any analgesia or anaesthesia; with regional anaesthetic injections as with paracervical block; using oral or intravenous analgesics and sedatives; or under general anaesthesia. Many gynaecologists use paracervical block for uterine intervention but it is unclear how effective and safe this method is. We included nine new studies in this updated review with a total of 26 studies involving 2790 women undergoing uterine interventions. The women were randomly allocated to paracervical block or an alternative. We found that, statistically, women had significantly less pain during cervical dilatation and uterine intervention with paracervical block than with placebo injection (saline or water) but clinically this difference may be unimportant. Paracervical block had no effect in five uncontrolled studies. There was no evidence that paracervical block reduced pain compared to alternative regional anaesthetic methods or systemic analgesics and sedatives. There was little information on important side effects. After updating, this review found that no local anaesthetic technique prevented pain as well as one would expect from general anaesthesia.

Resumen en términos sencillos

Anestesia local paracervical para la dilatación cervical y las intervenciones uterinas

El bloqueo paracervical incluye la inyección de un anestésico local alrededor del cuello uterino para adormecer los nervios cercanos. La dilatación cervical y las intervenciones uterinas (como histeroscopias, biopsias del endometrio, legrado fraccionado y abortos provocados por aspiración) se pueden realizar sin analgesia ni anestesia; con inyecciones regionales de anestésicos o con un bloqueo paracervical; el uso de analgésicos orales o intravenosos y sedantes; o bajo anestesia general. Muchos ginecólogos usan el bloqueo paracervical para la intervención uterina, pero no está claro cuán eficaz y seguro es este método. Se incluyeron nueve estudios nuevos en esta revisión actualizada, con un total de 26 estudios que incluyeron 2790 mujeres a las que se les realizaron intervenciones uterinas. Las pacientes fueron asignadas al azar a bloqueo paracervical o una alternativa. Se encontró que, estadísticamente, las pacientes tuvieron significativamente menos dolor durante la dilatación cervical y la intervención uterina con bloqueo paracervical que con inyección placebo (solución salina o agua) pero es posible que esta diferencia no sea clínicamente importante. El bloqueo paracervical no tuvo efectos en cinco estudios no controlados. No hubo pruebas de que el bloqueo paracervical alivió el dolor en comparación con métodos anestésicos regionales alternativos o analgésicos sistémicos y sedantes. Hubo muy poca información sobre efectos secundarios importantes. Después de la actualización esta revisión encontró que ninguna técnica anestésica local previno el dolor de forma tan efectiva como se esperaría de la anestesia general.

Notas de traducción

La traducción y edición de las revisiones Cochrane han sido realizadas bajo la responsabilidad del Centro Cochrane Iberoamericano, gracias a la suscripción efectuada por el Ministerio de Sanidad, Servicios Sociales e Igualdad del Gobierno español. Si detecta algún problema con la traducción, por favor, contacte con Infoglobal Suport, cochrane@infoglobal-suport.com.

Summary of findings(Explanation)

Summary of findings for the main comparison. Paracervical versus placebo for cervical dilatation and uterine intervention
  1. 1 Heterogeneity between studies may arise from differences in outcomes
    2 Limitation of design: lack of allocation concealment

Paracervical versus placebo for cervical dilation and uterine intervention
Patient or population: patients with cervical dilatation and uterine intervention
Settings:
Intervention: paracervical versus placebo
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Paracervical versus placebo
Pain dilating cervix The mean pain dilating cervix in the intervention groups was
0.37 standard deviations lower
(0.58 to 0.17 lower)
 381
(4 studies)
⊕⊕⊕⊕
high
SMD -0.37 (-0.58 to -0.17)
Pain during uterine intervention - Risk of any pain Study population RR 0.85
(0.54 to 1.34)
242
(2 studies)
⊕⊕⊝⊝
low 1
 
926 per 1000 787 per 1000
(500 to 1000)
Moderate
910 per 1000 773 per 1000
(491 to 1000)
Pain during uterine intervention - Risk of severe pain Study population RR 0.16
(0.04 to 0.74)
242
(2 studies)
⊕⊕⊕⊝
moderate 2
 
149 per 1000 24 per 1000
(6 to 110)
Moderate
156 per 1000 25 per 1000
(6 to 115)
Postoperative pain - Immediately after the procedure The mean postoperative pain - immediately after the procedure in the intervention groups was
0.34 standard deviations lower
(0.92 lower to 0.24 higher)
 223
(3 studies)
⊕⊕⊝⊝
low
SMD -0.34 (-0.92 to 0.24)
Adverse effects - Nausea and vomiting Study population RR 0.24
(0.02 to 2.8)
429
(3 studies)
⊕⊕⊕⊝
moderate
 
265 per 1000 64 per 1000
(5 to 742)
Moderate
250 per 1000 60 per 1000
(5 to 700)
Adverse effects - Sweating Study population RR 1.08
(0.7 to 1.67)
142
(1 study)
⊕⊕⊕⊝
moderate
 
352 per 1000 380 per 1000
(246 to 588)
Moderate
352 per 1000 380 per 1000
(246 to 588)
Adverse effects - Hypotension Study population RR 3.06
(1.21 to 7.78)
171
(2 studies)
⊕⊕⊕⊝
moderate
 
58 per 1000 178 per 1000
(70 to 452)
Moderate
50 per 1000 153 per 1000
(61 to 389)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2 Paracervical versus no anaesthesia for cervical dilatation and uterine intervention

Summary of findings 2. Paracervical versus no anaesthesia for cervical dilatation and uterine intervention
Paracervical versus no anaesthesia for cervical dilatation and uterine intervention
Patient or population: patients with cervical dilatation and uterine intervention
Settings:
Intervention: paracervical versus no anaesthesia
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Paracervical versus no anaesthesia
Pain during the procedure Study population OR 0.99
(0.52 to 1.86)
215
(1 study)
⊕⊕⊕⊕
high
 
769 per 1000 767 per 1000
(633 to 861)
Moderate
769 per 1000 767 per 1000
(634 to 861)
Postoperative pain at different times - Immediately after the procedure The mean postoperative pain at different times - immediately after the procedure in the intervention groups was
0.46 lower
(1.22 lower to 0.3 higher)
 273
(2 studies)
⊕⊕⊕⊕
high
 
Postoperative pain at different times - 5 minutes after the procedure The mean postoperative pain at different times - 5 minutes after the procedure in the intervention groups was
0.46 lower
(1.41 lower to 0.49 higher)
 58
(1)
See comment 
Postoperative pain at different times - 10 minutes after the procedure The mean postoperative pain at different times - 10 minutes after the procedure in the intervention groups was
0.04 lower
(0.69 lower to 0.61 higher)
 58
(1 study)
See comment 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 3 Paracervical block versus other regional anaesthesia for cervical dilatation and uterine intervention

Summary of findings 3. Paracervical block versus other regional anaesthesia for cervical dilatation and uterine intervention
  1. 1 Limitation of study: lack of allocation concealment, blinding
    2 Heterogeneity between studies may arise from differences of populations
    3 Heterogeneity between studies may arise from difference of outcomes
    4 Imprecision: the study had wide confidence intervals around the estimate of the effect
    5 Limitation of study: lack of blinding

Paracervical block versus other regional anaesthesia for cervical dilatation and uterine intervention
Patient or population: patients with cervical dilatation and uterine intervention
Settings:
Intervention: paracervical block versus other regional anaesthesia
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Paracervical block versus other regional anaesthesia
Pain during the procedure Study population OR 1.41
(0.68 to 2.91)
120
(1 study)
⊕⊕⊕⊝
moderate 1
 
383 per 1000 467 per 1000
(297 to 644)
Moderate
383 per 1000 467 per 1000
(297 to 644)
Pain during cervical dilatation The mean pain during cervical dilatation in the intervention groups was
0.52 lower
(1.28 lower to 0.24 higher)
 163
(2 studies)
⊕⊕⊝⊝
low 2
 
Pain during uterine intervention: continuousSee commentSee commentNot estimable271
(3 studies)
⊕⊝⊝⊝
very low 3,4
 
Postoperative pain at different time: continuousSee commentSee commentNot estimable307
(2 studies)
⊕⊕⊕⊕
high
 
Adverse effectsSee commentSee commentNot estimable55
(1 study)
⊕⊕⊝⊝
low 5
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 4 Paracervical versus systemic analgesia for cervical dilatation and uterine intervention

Summary of findings 4. Paracervical versus systemic analgesia for cervical dilatation and uterine intervention
  1. 1 Limitation of studies: lack of allocation concealment, blinding

Paracervical versus systemic analgesia for cervical dilatation and uterine intervention
Patient or population: patients with cervical dilatation and uterine intervention
Settings:
Intervention: paracervical versus systemic analgesia
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Paracervical versus systemic analgesia
Pain during uterine interventionSee commentSee commentNot estimable402
(3 studies)
⊕⊕⊝⊝
low 1
 
Postoperative painSee commentSee commentNot estimable984
(2 studies)
⊕⊕⊕⊕
high
 
Requirement for postoperative analgesicsSee commentSee commentNot estimable166
(1 study)
⊕⊕⊝⊝
low
 
Adverse effectsSee commentSee commentNot estimable571
(3 studies)
⊕⊕⊝⊝
low
 
Patient satisfaction Study populationNot estimable166
(1 study)
⊕⊕⊝⊝
low
 
940 per 1000 0 per 1000
(0 to 0)
Moderate
941 per 1000 0 per 1000
(0 to 0)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Indications for cervical dilatation and uterine intervention include abnormal uterine bleeding that does not respond to medical treatment, postmenopausal bleeding, and abortion. General anaesthesia provides adequate operating conditions for cervical dilatation and uterine intervention. However, there are some situations where general anaesthesia is hazardous, for example when patients are frail, unwell, or when no anaesthesiologist is available. The choice of anaesthesia and analgesia is dependent on effectiveness, cost, safety, and side effects. Other factors are the patient's and physician's preferences. Paracervical local anaesthesia offers an alternative for cervical dilatation and uterine intervention as it does not require general anaesthetic equipment or personnel trained to give general anaesthesia.

Description of the intervention

Paracervical block has been performed since 1925 (Aimakhu 1972). Injection of local anaesthetic around the cervix, at the 'three and nine o'clock positions', anaesthetizes the second to fourth sacral nerve roots as they pass through Frankenhäuser's plexus at a depth of 2 to 4 mm (Piyamongkol 1998). Physical pain originates from the S2 to S4 parasympathetic fibres (the Frankenhäuser plexus) that innervate the cervix and the lower part of the uterine body (Scott 1976; Smith 1991). The uterine fundus and lower part of the uterine body are innervated by sympathetic fibres from T10 to L1 via the inferior hypogastric nerve and the ovarian plexus (Maltzer 1999).

How the intervention might work

Most gynaecologic procedures cause pain or discomfort, especially on cervical dilatation. The pain is transmitted by sensory and sympathetic pathways to the lateral spinothalamic tracts of the spinal cord. Paracervical anaesthetics block transmission of pain through sympathetic, parasympathetic and sensory fibres before they enter the uterus at the level of the internal os (Chanrachakul 2001).

Why it is important to do this review

Many gynaecologists inject paracervical local anaesthetic before cervical dilatation and uterine intervention, but its effectiveness is unclear. The effectiveness of paracervical blockade may be affected by the anatomical and physiological changes that accompany pregnancy and the menopause. We compared the effectiveness and safety of paracervical blockade before cervical dilatation and uterine interventions versus no treatment, placebo, other methods of regional anaesthesia, sedation and systemic analgesia, and general anaesthesia.

Objectives

The objectives of this review were to determine the effectiveness and safety of paracervical local anaesthesia for cervical dilatation and uterine intervention, versus no treatment, placebo, other methods of regional anaesthesia, sedation and systemic analgesia, and general anaesthesia.

Methods

Criteria for considering studies for this review

Types of studies

We included randomized controlled trials (RCTs) in which allocation was either randomized or pseudo-randomized (alternate days, weeks, odd and even hospital numbers). We excluded concurrent cohort and observational studies.

Types of participants

We included women of any age who underwent cervical dilatation and uterine intervention for any indication.

Types of interventions

We included studies in which at least one group had paracervical block. The comparison interventions were: placebo; no treatment; other regional anaesthesia; sedation and systemic analgesia. We did not compare one type of local anaesthetic with another.

We anticipated that we would conduct meta-analyses for the following comparisons.

  1. Paracervical local anaesthesia versus placebo.

  2. Paracervical local anaesthesia versus no anaesthesia.

  3. Paracervical local anaesthesia versus other methods of regional anaesthesia.

  4. Paracervical local anaesthesia versus systemic analgesia.

  5. Paracervical local anaesthesia versus general anaesthesia.

Types of outcome measures

We included pain, adverse effects, and patient satisfaction.

Primary outcomes
  1. Pain during or after cervical dilatation and uterine intervention, measured as categorical or continuous data (for example on a visual analogue scale)

  2. Adverse effects (such as nausea, vomiting, hypotension)

  3. The requirement of additional analgesia

Secondary outcomes
  1. Patient satisfaction (as defined by the study authors)

Search methods for identification of studies

Electronic searches

We reran our search to August 2013. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2013, Issue 8) (Appendix 1), MEDLINE via OvidSP (1966 to August 2013) (Appendix 2), EMBASE via OvidSP (January 1980 to August 2013) (Appendix 3), and reference lists of articles. Our original search was performed in January 2006.

We combined our search strategies with the Cochrane highly sensitive search strategy for RCTs as contained in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

We searched for ongoing and recently published studies in www.controlled-studies.com. We did not apply any language restrictions.

Searching other resources

We handsearched the reference lists of reviews, randomized and non-randomized studies, and editorials for additional studies. We contacted the main authors of studies and experts in this field to ask for any missed, unreported, or ongoing studies.

Data collection and analysis

Selection of studies

We did not blind the names of the study authors, institutions, or journals of publication. Two authors (TT and US) independently evaluated the eligibility of studies from their title, abstract, and the full paper. We analysed the results of the randomized controlled studies that we had selected and graded their methodological quality by using the GradeProfiler programme version 3.2.2 and through construction of the risk of bias tables for the following items: random sequence generation; allocation concealment; blinding of the intervention administered; incomplete data; selective reporting; and other bias. We used the GradeProfiler programme version 3.2.2 to grade the quality of the relevant articles in terms of their: limitation of design; inconsistency; indirectness; imprecision; and publication bias. The quality of evidence across studies for the outcome was graded into four levels: high; moderate; low; and very low. We resolved any disagreements through discussion. The third author (PL) evaluated disputed studies to obtain a consensus.

Data extraction and management

We used the standard methods of the Cochrane Anaesthesia Review Group. Two authors (TT and US) scrutinized all the titles and abstracts for their suitability and independently extracted data. One author (TT) checked the data and entered them into RevMan 5.1. We contacted the authors of any study that had missing data.

Assessment of risk of bias in included studies

We evaluated the validity and design characteristics of each trial. We assessed: random sequence generation, allocation concealment, blinding, incomplete data, selective reporting, and other bias. We performed summary assessments of the risk of bias for each important outcome (across domains) within and across studies. We applied a 'Risk of bias' graph and a 'Risk of bias' summary figure (Higgins 2011) (Figure 1, Figure 2). We planned to include high and low risk studies, and to present multiple analyses.

Figure 1.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Unit of analysis issues

The unit of analysis was the individual participant. In this review we included only parallel group trials, with only one measurement per participant.

Dealing with missing data

We contacted Chanrachakul 2001 in order to retrieve the relevant data but the data were unavailable. We chose to explore selective outcome reporting by comparing publications with their protocols, if the latter were available.

Assessment of heterogeneity

When we suspected important heterogeneity, determined by an I2 statistic greater than 50% (Higgins 2003), we investigated differences in clinical factors between studies. When meta-analysis was inappropriate, we drew conclusions from the descriptive elements of the studies; methodological quality; number of studies with consistent findings; plausibility of the results; and the strength of the associations in the primary studies as well as consensus among authors.

Assessment of reporting biases

We planned to explore whether the included articles had any reporting biases, both publication and funding biases.

Data synthesis

Where appropriate, we analysed pooled data using RevMan 5.1. The method of meta-analysis was dependent on the nature of the outcomes. For categorical data (for example the proportion of participants with an event) we related the number reporting an event to the number at risk in each group to derive a relative risk (RR) and 95% confidence interval (CI). We pooled continuous differences between groups in the meta-analysis (for example pain relief on a visual analogue scale (VAS)) as mean differences (MD) or standardized mean differences (SMD), as appropriate, with their 95% CIs. In the case of various units of pain score measurements among studies, we used SMD for analysis. We used a fixed-effect model unless significant heterogeneity was encountered, in which case we used a random-effects model.

Subgroup analysis and investigation of heterogeneity

We considered subgroup analyses based on:

  • patients' characteristics e.g. menopausal status (before versus after), parity (zero versus the rest);

  • types of diseases;

  • nature, dose, and duration of interventions.

We did not perform any subgroup and sensitivity analyses because of the small number of included studies; and no data were available on potential factors for subgroup analysis.

Sensitivity analysis

We planned the following sensitivity analyses: quality of allocation concealment (adequate, unclear, or inadequate); blinding outcome assessment (adequate, unclear, or inadequate or not performed); and rates of withdrawals for each outcome.

Results

Description of studies

Results of the search

We identified 1218 studies of which 96 had relevant titles and abstracts. We excluded 10 of these studies (Agostini 2008; Allen 2006; Allen 2009; Cansino 2009; Habersetzer 1972; Harper 1997; Karasahin 2011; Manyou 2008; Naki 2011; Phittayawechwiwat 2007) (see Characteristics of excluded studies). We excluded 70 studies in total (Figure 3). We found no ongoing trials. Titles and abstracts were unclear in three studies (Chaudhuri 1980; Regina 1987; Sen 1980) and we put them into 'Studies awaiting classification'. We identified 26 relevant studies with 28 comparisons as Kan 2004 and Sharma 2009 studied more than two groups (see Characteristics of included studies), involving a total of 2790 women, that were published in full. Our full search results are in Figure 3.

Figure 3.

Searching results

Included studies

In our original review we included 17 studies. In this updated review we included nine new studies (Al-Sunaidi 2007; Amirian 2009; Chudnoff 2010; Lazenby 2009; Lopez 2007; Mankowski 2009; Renner 2012; Sharma 2009; Thongrong 2011) making a total of 26 studies. Two of the new studies compared paracervical block versus placebo (Amirian 2009; Chudnoff 2010) making a total of 10 studies. We included three additional studies (Lopez 2007; Sharma 2009; Thongrong 2011) of paracervical block versus sedation and systemic analgesia; two additional studies (Al-Sunaidi 2007; Mankowski 2009) versus other regional techniques; and one additional study versus no treatment (Renner 2012). We did not find any studies of paracervical block versus general anaesthesia.

Excluded studies

In our original review, we excluded 80 studies.

In our updated review we excluded an additional 10 newly identified studies (Agostini 2008; Allen 2006; Allen 2009; Cansino 2009; Habersetzer 1972; Harper 1997; Karasahin 2011; Manyou 2008; Naki 2011; Phittayawechwiwat 2007). We then re-evaluated the studies we had excluded in our previous review. We removed 18 studies from the list of excluded studies as they were not RCTs (Amyot-Legault 1981; Coker 1968; Fernandez 1997; Ferry 1994; Formiga-Filho 1974; Gad 1967; Lewis 1971; Littlepage 1969; Readman 2004; Reguer Noriega 1973; Rotchell 1976; Sandmire 1974; Santonja 1974; Strausz 1971; Thonneau 1998; Toth 2000; Van Praagh 1967; Walden 1973).

Studies awaiting classification

Three studies remain unavailable to us in full text (Chaudhuri 1980; Regina 1987; Sen 1980).

Risk of bias in included studies

Please see the table Characteristics of included studies for the detailed descriptions of bias. The domains of bias are presented in the 'Risk of bias' graph and 'Risk of bias' summary figures (Figure 1, Figure 2).

Allocation

We judged 17 studies to have a low risk of bias for random sequence generation (Al-Sunaidi 2007; Amirian 2009; Carroll 2005; Chanrachakul 2001; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Gómez 2004; Guida 2003; Kan 2004; Lau 1999; Lopez 2007; Mankowski 2009; Renner 2012; Sharma 2009; Vercellini 1994). There was an unclear risk of bias in seven studies (Buppasiri 2005; Chatfield 1970; Lazenby 2009; Miller 1996; Mola 1996; Titapant 2003; Yazaci 2003), and a high risk of bias in two studies (Finikiotis 1992; Thongrong 2011). We judged allocation concealment to be low risk of bias in 14 studies (Amirian 2009; Carroll 2005; Chanrachakul 2001; Chudnoff 2010; Cicinelli 1998; Glantz 2001; Gómez 2004; Kan 2004; Lau 1999; Lazenby 2009; Lopez 2007; Mankowski 2009; Mola 1996; Renner 2012), unclear in six studies (Buppasiri 2005; Egziabher 2002; Guida 2003; Miller 1996; Titapant 2003; Yazaci 2003), and at a high risk of bias in six studies (Al-Sunaidi 2007; Chatfield 1970; Finikiotis 1992; Sharma 2009; Thongrong 2011; Vercellini 1994).

Blinding

Of the 26 studies, 15 adequately blinded women to their allocated intervention (Amirian 2009; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Gómez 2004; Kan 2004; Lau 1999; Lazenby 2009; Mankowski 2009; Miller 1996; Renner 2012; Titapant 2003). Nine studies adequately blinded treatment providers to the allocated intervention (Amirian 2009; Chanrachakul 2001; Chatfield 1970; Cicinelli 1998; Egziabher 2002; Glantz 2001; Lau 1999; Miller 1996; Titapant 2003). Thirteen studies adequately blinded outcome assessors to the allocated intervention (Amirian 2009; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Gómez 2004; Kan 2004; Lau 1999; Miller 1996; Renner 2012; Titapant 2003). Three of these studies (Chatfield 1970; Cicinelli 1998; Glantz 2001) blinded assessors to outcomes other than abdominal pain.

Incomplete outcome data

All studies completed follow up for all women. Seven studies were at high risk of incomplete outcome data (Al-Sunaidi 2007; Amirian 2009; Buppasiri 2005; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Kan 2004; Lau 1999; Lazenby 2009); risk of attrition bias was unclear in two (Finikiotis 1992; Mola 1996), and low in 17 studies (Carroll 2005; Egziabher 2002; Glantz 2001; Guida 2003; Gómez 2004; Kan 2004; Lau 1999; Lazenby 2009; Lopez 2007; Mankowski 2009; Miller 1996; Renner 2012; Sharma 2009; Thongrong 2011; Titapant 2003; Vercellini 1994; Yazaci 2003).

Selective reporting

Of the 26 studies, 24 were free of selective reporting (Al-Sunaidi 2007; Amirian 2009; Buppasiri 2005; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Finikiotis 1992; Glantz 2001; Gómez 2004; Guida 2003; Kan 2004; Lau 1999; Lazenby 2009; Lopez 2007; Mankowski 2009; Miller 1996; Mola 1996; Sharma 2009; Thongrong 2011; Titapant 2003; Vercellini 1994; Yazaci 2003), one was unclear (Carroll 2005), and one was at high risk (Renner 2012) (see Figure 1, Figure 2).

Other potential sources of bias

Two studies (Kan 2004; Lazenby 2009) presented the trust fund information. Sample size calculations were presented in 14 studies (Chanrachakul 2001; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Gómez 2004; Guida 2003; Kan 2004; Lau 1999; Lazenby 2009; Lopez 2007; Renner 2012; Thongrong 2011; Vercellini 1994). Amirian 2009 excluded the participants who had uterine perforation or severe bleeding during curettage after the allocation concealment was performed. We judged one study to be unclear of other potential biases (Al-Sunaidi 2007).

Effects of interventions

See: Summary of findings for the main comparison Paracervical versus placebo for cervical dilatation and uterine intervention; Summary of findings 2 Paracervical versus no anaesthesia for cervical dilatation and uterine intervention; Summary of findings 3 Paracervical block versus other regional anaesthesia for cervical dilatation and uterine intervention; Summary of findings 4 Paracervical versus systemic analgesia for cervical dilatation and uterine intervention

Paracervical local anaesthesia versus placebo

(Analysis 1.1 to Analysis 1.9)
Ten studies compared paracervical block versus placebo (Amirian 2009; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Lau 1999; Miller 1996; Titapant 2003). Uterine interventions included hysteroscopy, endometrial biopsy, fractional curettage, and vacuum aspiration. The local anaesthetics used were lidocaine, chloroprocaine, and xylocaine (see Characteristics of included studies for details).

Pain during speculum insertion (Analysis 1.1)

There was no evidence of an effect of paracervical block, SMD 0.20 (95% CI -0.35 to 0.74).

Pain on tenaculum placement (Analysis 1.2)

There was no evidence of an effect of paracervical block, MD -0.70 (95% CI -2.26 to 0.86).

Pain dilating cervix (Analysis 1.3)

There was evidence that paracervical block reduced the pain of cervical dilatation, SMD -0.39 (95% CI -0.72 to -0.07).

Pain during uterine interventions (Analysis 1.4)

There was evidence that paracervical block reduced the pain of uterine interventions (carbon dioxide insufflation, endometrial biopsy, fractional curettage, suction evacuation, or aspiration), SMD -0.74 (95% CI -1.19 to -0.28). However, there was substantial heterogeneity across these subgroups (I2 = 85%, P < 0.0001). Within the subgroups there was evidence of an effect for endometrial biopsy and suction aspiration (SMD -1.71, 95% CI -2.26 to -1.17; and SMD -0.90, 95% CI -1.47 to -0.32 respectively).

Pain during uterine interventions (risk of pain) (Analysis 1.5, Analysis 1.6)

There was evidence that paracervical block reduced the risk of severe pain but not any pain (RR 0.16, 95% CI 0.04 to 0.74; RR 0.87, 95% CI 0.68 to 1.12 respectively). Chanrachakul 2001 reported that paracervical block significantly reduced the median pain score during fractional curettage, from 6.0 to 4.0 (statement unsupported by a P value). There was no evidence of an effect in a study of tubal insert placement (Chudnoff 2010) (see Additional Table 1, Appendix 4).

Table 1. Pain: paracervical local anaesthesia versus placebo, single study analyses
OutcomeStudyParticipantsStatistical methodEffect estimate
Pain on intracervical injection Chudnoff 201080Mean Difference (IV, Fixed, 95%CI)-0.63 [-1.33 to 0.07]

Postoperative pain (Analysis 1.7)

There was no evidence that paracervical block reliably reduced postoperative pain (see also Appendix 5, Appendix 6, Appendix 7).

Shoulder pain (Analysis 1.8)

There was no evidence that paracervical block reduced the risk of shoulder pain.

Adverse effects (Analysis 1.9)

Paracervical block did not change the risk of sweating, nausea or vomiting. In one study (Lau 1999) the risk of hypotension after paracervical block was greater than after placebo injection, RR 3.06 (95% CI 1.21 to 7.78). In Miller 1996 3/27 women developed symptoms consistent with lidocaine toxicity (tingling lips, dizziness).

Additional drug requirement

There was no evidence that paracervical block reduced the need for additional drugs, including general anaesthesia (Amirian 2009) (see Appendix 8, Appendix 9).

Paracervical local anaesthesia versus no anaesthesia

(Analysis 2.1)

Six studies compared paracervical block versus no treatment (Carroll 2005; Gómez 2004; Kan 2004; Lazenby 2009; Renner 2012; Vercellini 1994). In two studies women had a hysteroscopy (Carroll 2005; Vercellini 1994) and in four studies women had suction termination or evacuation of incomplete miscarriages (Gómez 2004; Kan 2004; Lazenby 2009; Renner 2012).

Pain during the procedure

Meta-analysis was not performed for this outcome. Kan 2004 and Lazenby 2009 found no evidence that paracervical block reduced median pain scores during or after suction termination under sedation when compared to no block. Gómez 2004 reported no difference in intraoperative pain as recalled 10 minutes after the procedure (Appendix 10). There was no evidence for significant differences in pain during hysteroscopy and endometrial biopsy in Vercellini 1994 (Additional Table 2), but Renner 2012 reported different results on pain reduction (Additional Table 2). This study found that baseline pain and pain on speculum insertion were not significantly different between paracervical local anaesthesia and no treatment (Appendix 11, Appendix 12). Pain during paracervical injection was greater in the paracervical local anaesthesia group (Appendix 13) but pain on cervical dilation and aspiration was significantly lower with paracervical local anaesthesia than with no treatment (Appendix 14, Appendix 15).

Table 2. Pain during uterine intervention: paracervical local anaesthesia versus no anaesthesia, single study analyses
OutcomesStudyParticipantsStatistical methodEffect estimate
Hysteroscopy Vercellini 1994177Mean Difference (IV, Random, 95%CI)-0.40 [-1.02 to 0.22]
Endometrial biopsy Vercellini 1994177Mean Difference (IV, Random, 95%CI)-0.50 [-1.16 to 0.16]
Aspiration Renner 2012120Mean Difference (IV, Fixed, 95% CI)-26.00 [-33.48, -18.52]

Postoperative pain (Analysis 2.1)

There was no evidence that paracervical block reduced postoperative pain (also see Appendix 16).

Adverse effects

No study found evidence for differences in the risks of adverse effects.

Patient satisfaction

Kan 2004 did not find evidence for differences in patient satisfaction. Renner 2012 found that paracervical block increased the median satisfaction with pain control and with the procedure (73 versus 49, P < 0.01; and 90 versus 84, P = 0.04 respectively).

Requirement of additional analgesia

There was no evidence that paracervical block affected this outcome (Renner 2012).

Paracervical local anaesthesia versus other regional anaesthesia

(Analysis 3.1 to Analysis 3.3)

Five studies (Al-Sunaidi 2007; Finikiotis 1992; Kan 2004; Mankowski 2009; Yazaci 2003) compared paracervical block to other local anaesthetic techniques: uterosacral block (Finikiotis 1992), intracervical block (Al-Sunaidi 2007; Kan 2004; Mankowski 2009), and intrauterine topical analgesia (Yazaci 2003).

Pain during cervical dilatation (Analysis 3.1)

There was no evidence that paracervical block affected this outcome.

Pain during uterine intervention (Analysis 3.2)

Statistically, the studies were too heterogeneous to summate. There was no evidence that paracervical block reduced severe pain, moderate or severe pain during hysteroscopy (Finikiotis 1992) (RR 0.17, 95% CI 0.42 to 3.27; and RR 1.22, 95% CI 0.80 to 1.85 respectively), see Appendix 17. Yazaci 2003 reported that intrauterine instillation of local anaesthetic caused worse pain than paracervical block, SMD 9.49 (95% CI 4.20 to 14.78) (Appendix 18). There was no evidence that pain was different during suction termination under sedation with paracervical block versus intracervical block (Kan 2004), or during hysteroscopy (Al-Sunaidi 2007) or uterine curettage (Mankowski 2009). Paracervical block slightly reduced pain during endometrial biopsy compared with intrauterine local anaesthetic installation, MD on a 100-point scale of 6.9 (95% CI 2.5 to 11.3, P = 0.002) (Yazaci 2003), see Additional Table 3.

Table 3. Pain during uterine intervention: paracervical local anaesthesia versus other regional anaesthesia, single study analyses
OutcomesStudyParticipantsStatistical methodEffect estimate
Endometrial biopsy Yazaci 2003114Mean Difference (IV, Random, 95%CI)-6.92 [-11.27 to -2.57]
Uterine curettage Mankowski 2009132Mean Difference (IV, Random, 95%CI)0.60 [-0.32 to 1.52]
Hysteroscopy Al-Sunaidi 200784Mean Difference (IV, Random, 95%CI)-1.10 [-1.21 to -0.99]

Postoperative pain at different times (Analysis 3.3)

The studies were statistically too heterogeneous to summate. Paracervical block reduced postoperative pain in two studies (MD 4.63, 95% CI 0.24 to 9.02 (Yazaci 2003); and MD 0.40, 95% CI 0.29 to 0.51 (Al-Sunaidi 2007) at 10 minutes, MD 0.70, 95% CI 0.61 to 0.79 at 30 minutes, and MD 0.20, 95% CI 0.13 to 0.27 at 60 minutes postoperation) (see Appendix 19).

Adverse effects

Yazaci 2003 did not find any difference in the risk of a vasovagal reaction (Appendix 20).

Paracervical local anaesthesia versus systemic analgesia

(Analysis 4.1 to Analysis 4.3)

Six studies (Buppasiri 2005; Guida 2003; Lopez 2007; Mola 1996; Sharma 2009; Thongrong 2011) compared paracervical block with systemic analgesics and sedatives: mefenamic acid (Buppasiri 2005); fentanyl and midazolam (Guida 2003); paracervical block plus diclofenac and meperidine plus diclofenac (Lopez 2007); pethidine and diazepam (Mola 1996); drotaverine with mefenamic acid and diazepam with pentazocine (Sharma 2009); and intravenous morphine (Thongrong 2011). The studies included women undergoing: fractional curettage (Buppasiri 2005; Thongrong 2011); hysteroscopy (Guida 2003); manual vacuum aspiration (Lopez 2007); bi-manual removal of retained placenta (Mola 1996); hysteroscopy with endometrial biopsy (Sharma 2009).

Pain during uterine intervention (Analysis 4.1)

The studies were statistically too heterogeneous to summate. There was no evidence that pain during uterine intervention differed with paracervical block compared to systemic analgesia (also see Appendix 21 and Appendix 22).

Postoperative pain (Analysis 4.2)

Statistically the studies were too heterogeneous to summate. There was no evidence that pain after uterine intervention differed with paracervical block compared with systemic analgesia (also see Appendix 23).

Adverse effects (Analysis 4.3)

There was no evidence that the rates of pallor, hypotension, dizziness, or nausea or vomiting differed with paracervical block compared with systemic analgesia.

Requirement for postoperative analgesia

There was no evidence that the rates or doses of postoperative analgesics differed with paracervical block versus systemic analgesia. Buppasiri 2005 reported that three patients in each group needed additional drugs (intravenous pethidine). Guida 2003 and Lopez 2007 reported no significant difference in postoperative analgesic requirement between paracervical block and systemic analgesia (Appendix 24).

Patient satisfaction

There was no evidence for a difference in this outcome (see Appendix 25, Appendix 26).

Paracervical local anaesthesia versus general anaesthesia

We found no studies for this comparison.

Subgroup analysis

We did not perform any subgroup analysis because of the small number of included studies, and no data were available on potential factors for subgroup analysis.

Sensitivity analysis

We did not do sensitivity analyses because few studies were included in the review.

Discussion

Summary of main results

Twenty-six included studies involving 2790 women compared paracervical block and other anaesthetic and analgesic methods for women undergoing uterine interventions. There was little evidence to support the belief that paracervical block made any consistent difference to any outcome.

Overall completeness and applicability of evidence

We were unable to assess the comparative effects of paracervical local anaesthesia (PLA) versus general anaesthesia as we did not find any studies. There appeared to be sufficient studies and measurements to address the other objectives of this review. Ten included studies, with 984 women, compared paracervical block with placebo (Amirian 2009; Chanrachakul 2001; Chatfield 1970; Chudnoff 2010; Cicinelli 1998; Egziabher 2002; Glantz 2001; Lau 1999; Miller 1996; Titapant 2003). PLA was compared with no anaesthesia in six studies (776 women) (Carroll 2005; Gómez 2004; Kan 2004; Lazenby 2009; Renner 2012; Vercellini 1994), with other regional anaesthesia methods in five studies (450 women) (Al-Sunaidi 2007; Finikiotis 1992; Mankowski 2009; Kan 2004; Yazaci 2003), and systemic analgesia in six studies (580 women) (Buppasiri 2005; Guida 2003; Lopez 2007; Mola 1996; Sharma 2009; Thongrong 2011). All 26 studies measured pain as an outcome. Ten studies (Buppasiri 2005; Cicinelli 1998; Egziabher 2002; Guida 2003; Kan 2004; Lau 1999; Miller 1996; Renner 2012; Thongrong 2011; Yazaci 2003) had information on adverse effects, three studies reported patient satisfaction (Guida 2003; Kan 2004; Renner 2012), and five studies reported on postoperative analgesic requirements (Amirian 2009; Gómez 2004; Kan 2004; Lazenby 2009; Renner 2012). The women included in this review underwent both obstetric (dilatation curettage, manual placenta removal, manual vacuum aspiration) and gynaecologic (hysteroscopy, fractional curettage, endometrial biopsy or ablation) interventions.

Quality of the evidence

Fourteen of the 26 included studies (Amirian 2009; Carroll 2005; Chanrachakul 2001; Chudnoff 2010; Cicinelli 1998; Glantz 2001; Gómez 2004; Kan 2004; Lau 1999; Lazenby 2009; Lopez 2007; Mankowski 2009; Mola 1996; Renner 2012) had adequate random allocation concealment but we could not perform sensitivity analyses to evaluate the robustness of the result. This was because we had more than one comparison and each comparison had a limited number of included studies. Of the 26 included studies, 15 reported using some form of blinding. In conclusion, half of the included studies had adequate quality in terms of randomised allocation concealment and blinding.

Potential biases in the review process

We strictly followed the search strategies recommended by the Cochrane Anaesthesia Review Group (CARG). We searched all recommended databases and retrieved all the potential studies, except for three that remain unavailable in full text (Chaudhuri 1980; Regina 1987; Sen 1980). Since we used the recommended review process described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) any bias in the review should be minimal.

Authors' conclusions

Implications for practice

All of the techniques used in the 26 included studies failed to reliably prevent pain in conscious women having uterine interventions. The available evidence does not show if paracervical block is inferior, equivalent, or superior to the alternative analgesic techniques, either in terms of efficacy or safety. Some women are likely to experience severe pain if they undergo uterine interventions with paracervical blockade, or one of the other conscious methods assessed in this review. Either general anaesthesia or neuraxial blockade is probably necessary to avoid severe pain during uterine intervention. Clinicians should stop using paracervical block as a method of pain control.

Implications for research

Our systematic review showed that pain experienced by women having uterine interventions is inadequately controlled by paracervical block. The findings of the 26 included studies suggest that the other methods that were compared with paracervical block (local anaesthetic methods, sedation and systemic analgesics) also inadequately control the pain. Researchers should conduct systematic reviews of these other methods to confirm or refute this finding. Should they do so, potential participants in trials should be informed of the results of this systematic review, which should also inform the design of any future randomized controlled trials.

Acknowledgements

As part of the pre-publication editorial process, this review has been commented on by content and statistical editors, two peer referees (who are external to the editorial team), one or more members of the Cochrane Consumer Network’s international panel of consumers, and the Anaesthesia Group’s Trials Search Co-ordinator.

We would like to thank John Carlisle, Nathan Pace, Martin Sowter, Steven Knight, Amy Woodruffe, and Kathie Godfrey for their help and editorial advice during the preparation of this review.

Special thanks to Jane Cracknell for providing valuable advice, support, encouragement and feedback; Karen Hovhannisyan for his help and advice; and Tom Pederson, Anne Roelsgaard Obling and Nete Villebro for their advice, encouragement and support during the preparation of this review.

Data and analyses

Download statistical data

Comparison 1. Paracervical versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain on speculum insertion2202Std. Mean Difference (IV, Random, 95% CI)0.20 [-0.35, 0.74]
2 Pain on tenaculum placement3249Mean Difference (IV, Random, 95% CI)-0.70 [-2.26, 0.86]
3 Pain dilating cervix4381Mean Difference (IV, Random, 95% CI)-0.96 [-1.91, -0.01]
4 Pain during uterine interventions6696Std. Mean Difference (IV, Random, 95% CI)-0.74 [-1.19, -0.28]
4.1 Pain when the uterus is distended by carbon dioxide199Std. Mean Difference (IV, Random, 95% CI)0.0 [-0.39, 0.39]
4.2 hysteroscopy172Std. Mean Difference (IV, Random, 95% CI)-1.71 [-2.26, -1.17]
4.3 Endometrial biopsy2171Std. Mean Difference (IV, Random, 95% CI)-0.85 [-2.44, 0.74]
4.4 Uterine curettage2220Std. Mean Difference (IV, Random, 95% CI)-0.90 [-1.47, -0.32]
4.5 Suction evacuation or aspiration2134Std. Mean Difference (IV, Random, 95% CI)-0.38 [-1.02, 0.25]
5 Risk of any pain during uterine interventions2242Risk Ratio (M-H, Random, 95% CI)0.87 [0.68, 1.12]
6 Risk of severe pain during uterine intervention2242Risk Ratio (M-H, Random, 95% CI)0.16 [0.04, 0.74]
7 Postoperative pain6 Std. Mean Difference (IV, Random, 95% CI)Subtotals only
7.1 Immediately after the procedure3223Std. Mean Difference (IV, Random, 95% CI)-0.34 [-0.92, 0.24]
7.2 5 min after the procedure180Std. Mean Difference (IV, Random, 95% CI)0.09 [-0.35, 0.53]
7.3 15 minutes after the procedure172Std. Mean Difference (IV, Random, 95% CI)-0.94 [-1.43, -0.45]
7.4 30 minutes after the procedure4371Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.26, 0.18]
8 Shoulder pain2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 During the procedure2144Risk Ratio (M-H, Fixed, 95% CI)0.5 [0.05, 5.39]
8.2 After the procedure2241Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.51, 3.49]
9 Adverse effects4 Risk Ratio (M-H, Random, 95% CI)Subtotals only
9.1 Nausea/vomiting3429Risk Ratio (M-H, Random, 95% CI)0.24 [0.02, 2.80]
9.2 Sweating1142Risk Ratio (M-H, Random, 95% CI)1.08 [0.70, 1.67]
9.3 Hypotension2171Risk Ratio (M-H, Random, 95% CI)3.06 [1.21, 7.78]
Analysis 1.1.

Comparison 1 Paracervical versus placebo, Outcome 1 Pain on speculum insertion.

Analysis 1.2.

Comparison 1 Paracervical versus placebo, Outcome 2 Pain on tenaculum placement.

Analysis 1.3.

Comparison 1 Paracervical versus placebo, Outcome 3 Pain dilating cervix.

Analysis 1.4.

Comparison 1 Paracervical versus placebo, Outcome 4 Pain during uterine interventions.

Analysis 1.5.

Comparison 1 Paracervical versus placebo, Outcome 5 Risk of any pain during uterine interventions.

Analysis 1.6.

Comparison 1 Paracervical versus placebo, Outcome 6 Risk of severe pain during uterine intervention.

Analysis 1.7.

Comparison 1 Paracervical versus placebo, Outcome 7 Postoperative pain.

Analysis 1.8.

Comparison 1 Paracervical versus placebo, Outcome 8 Shoulder pain.

Analysis 1.9.

Comparison 1 Paracervical versus placebo, Outcome 9 Adverse effects.

Comparison 2. Paracervical versus no anaesthesia
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Postoperative pain at different times2 Std. Mean Difference (IV, Fixed, 95% CI)Subtotals only
1.1 Immediately after the procedure2128Std. Mean Difference (IV, Fixed, 95% CI)-0.37 [-0.72, -0.02]
1.2 5 minutes after the procedure158Std. Mean Difference (IV, Fixed, 95% CI)-0.25 [-0.77, 0.27]
1.3 10 minutes after the procedure158Std. Mean Difference (IV, Fixed, 95% CI)-0.03 [-0.55, 0.48]
Analysis 2.1.

Comparison 2 Paracervical versus no anaesthesia, Outcome 1 Postoperative pain at different times.

Comparison 3. Paracervical block versus other regional anaesthesia
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain during cervical dilatation2163Std. Mean Difference (IV, Random, 95% CI)-1.04 [-2.99, 0.91]
2 Pain during uterine intervention: continuous3271Mean Difference (IV, Random, 95% CI)-0.55 [-1.24, 0.13]
2.1 Endometrial biopsy155Mean Difference (IV, Random, 95% CI)-0.69 [-1.13, -0.25]
2.2 Uterine curettage1132Mean Difference (IV, Random, 95% CI)0.60 [-0.32, 1.52]
2.3 Hysteroscopy184Mean Difference (IV, Random, 95% CI)-1.1 [-1.21, -0.99]
3 Postoperative pain at different time: continuous2307Mean Difference (IV, Fixed, 95% CI)-0.39 [-0.44, -0.35]
3.1 10 minutes after the procedure184Mean Difference (IV, Fixed, 95% CI)-0.40 [-0.51, -0.29]
3.2 15 minutes after the procedure155Mean Difference (IV, Fixed, 95% CI)-0.46 [-0.90, -0.02]
3.3 30 minutes after the procedure184Mean Difference (IV, Fixed, 95% CI)-0.7 [-0.79, -0.61]
3.4 60 minutes after the procedure184Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.27, -0.13]
Analysis 3.1.

Comparison 3 Paracervical block versus other regional anaesthesia, Outcome 1 Pain during cervical dilatation.

Analysis 3.2.

Comparison 3 Paracervical block versus other regional anaesthesia, Outcome 2 Pain during uterine intervention: continuous.

Analysis 3.3.

Comparison 3 Paracervical block versus other regional anaesthesia, Outcome 3 Postoperative pain at different time: continuous.

Comparison 4. Paracervical versus systemic analgesia
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain during uterine intervention3362Mean Difference (IV, Fixed, 95% CI)0.36 [0.16, 0.57]
1.1 hysteroscopic electrosurgery1166Mean Difference (IV, Fixed, 95% CI)0.20 [-0.03, 0.43]
1.2 manual vacuum aspiration176Mean Difference (IV, Fixed, 95% CI)0.40 [-0.82, 1.62]
1.3 Hysteroscopy and endometrial biopsy:1160Mean Difference (IV, Fixed, 95% CI)1.80 [1.12, 2.48]
1.4 Hysteroscopy and endometrial biopsy:2160Mean Difference (IV, Fixed, 95% CI)0.35 [-0.37, 1.07]
2 Postoperative pain2904Mean Difference (IV, Fixed, 95% CI)-0.00 [-0.03, 0.03]
2.1 at 15 minutes1166Mean Difference (IV, Fixed, 95% CI)0.10 [-0.19, 0.39]
2.2 at 30 minutes1120Mean Difference (IV, Fixed, 95% CI)0.53 [0.21, 0.85]
2.3 at 1 hour2286Mean Difference (IV, Fixed, 95% CI)0.42 [0.23, 0.62]
2.4 at 24 hours1166Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.31, -0.09]
2.5 at 3 days1166Mean Difference (IV, Fixed, 95% CI)0.0 [-0.03, 0.03]
3 Adverse effects3571Risk Ratio (M-H, Random, 95% CI)0.51 [0.21, 1.20]
3.1 Pallor or hypotension1166Risk Ratio (M-H, Random, 95% CI)0.82 [0.23, 2.94]
3.2 Nausea and vomiting2242Risk Ratio (M-H, Random, 95% CI)0.38 [0.10, 1.50]
3.3 Dizziness2163Risk Ratio (M-H, Random, 95% CI)1.01 [0.04, 25.55]
Analysis 4.1.

Comparison 4 Paracervical versus systemic analgesia, Outcome 1 Pain during uterine intervention.

Analysis 4.2.

Comparison 4 Paracervical versus systemic analgesia, Outcome 2 Postoperative pain.

Analysis 4.3.

Comparison 4 Paracervical versus systemic analgesia, Outcome 3 Adverse effects.

Appendices

Appendix 1. Search strategy for CENTRAL (The Cochrane Library)

#1 paracerv* or (paracerv* near an?esth*) or (paracerv* near block*) or (lidocain* or lignocain* or bupivacain* or marcain* or levobupivacain* or prilocain* or chlorprocain* or procain* or xylocain* or ropivacain* or tetracain* or amethocain* or mepivacain*)
#2 MeSH descriptor Anesthesia, Obstetrical explode all trees
#3 (#1 OR #2)
#4 ((obstet* or cervic* or uter*) near intervent*)
#5 (cervic* near dilat*)
#6 (curett* or dilat*):ti,ab
#7 MeSH descriptor Dilatation and Curettage explode all trees
#8 (vacuum near (extract* or aspirat*))
#9 MeSH descriptor Vacuum Curettage explode all trees
#10 MeSH descriptor Vacuum Extraction, Obstetrical explode all trees
#11 (#4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10)
#12 (#3 AND #11)

Appendix 2. Search strategy for MEDLINE (OvidSP)

1. (paracerv* or (paracerv* adj6 an?esth*) or (paracerv* adj3 block*) or (lidocain* or lignocain* or bupivacain* or marcain* or levobupivacain* or prilocain* or chlorprocain* or procain* or xylocain* or ropivacain* or tetracain* or amethocain* or mepivacain*)).mp.
2. exp Anesthesia Obstetrical/
3. 1 or 2
4. exp "Dilatation and Curettage"/
5. (((obstet* or cervic* or uter*) adj5 intervent*) or (cervic* adj5 dilat*)).mp. or (curett* or dilat*).ti,ab. or (vacuum adj3 (extract* or aspirat*)).mp.
6. exp Vacuum Curettage/ or exp Vacuum Extraction, Obstetrical/
7. 6 or 4 or 5
8. 3 and 7
9. ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab.) not (animals not (humans and animals)).sh.
10. 8 and 9

Appendix 3. Search strategy for EMBASE (OvidSP)

1. exp uterine cervix dilatation/ or curettage/ or exp vacuum extractor/ or exp vacuum 
extraction/ or ((obstet* or cervic* or uter*) adj5 intervent*).mp. or (cervic* adj5 
dilat*).mp. or (vacuum adj3 (extract* or aspirat*)).mp. or (curett* or dilat*).ti,ab.
2. exp obstetric anesthesia/ or exp paracervical block/ or (paracerv* or (paracerv* 
adj6 an?esth*)).mp. or (paracerv* adj3 block*).mp. or (lidocain* or lignocain* or bupivacain* or marcain* or levobupivacain* or prilocain* or chlorprocain* or procain* or xylocain* or ropivacain* or tetracain* or amethocain* or mepivacain*).mp.
3. 1 and 2
4. (randomized-controlled-trial/ or randomization/ or controlled-study/ or  
multicenter-study/ or phase-3-clinical-trial/ or phase-4-clinical-trial/ or double- 
blind-procedure/ or single-blind-procedure/ or (random* or cross?over* or factorial*  
or placebo* or volunteer* or ((singl* or doubl* or trebl* or tripl*) adj3 (blind* or  
mask*))).ti,ab.) not (animals not (humans and animals)).sh.
5. 3 and 4

Appendix 4. Placement of tubal insert: PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Placement of tubal insert Chudnoff 201080Mean Difference (IV, Random, 95%CI)-0.59 [-1.78 to 0.60]

Appendix 5. Postoperative abdominal pain (mild to moderate): PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Immediately after surgery Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.72 [0.61 to 0.85]
30 minutes after surgery Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.40 [0.26 to 0.60]

Appendix 6. Postoperative abdominal pain (severe): PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Immediately after surgery Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.33 [0.04 to 3.13]
30 minutes after surgery Egziabher 2002142Risk ratio (M-H, Random, 95%CI)No total

Appendix 7. Back pain: PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
During procedure Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.67 [0.50 to 0,90]
15 minutes after procedure Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.26 [0.10 to 0.67]
30 minutes after procedure Egziabher 2002142Risk ratio (M-H, Random, 95%CI)0.43 [0.12 to 1.59]

Appendix 8. Additional drug requirement: PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Additional drug requirement Amirian 2009150Odds Ratio (M-H, Fixed, 95%CI)0.78 [0.35 to 1.73]

Appendix 9. Need for general anaesthesia: PLA versus placebo, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Need for GA Amirian 2009150Odds Ratio (M-H, Fixed, 95%CI)0.59 [0.24 to 1.47]

Appendix 10. Pain during the procedure: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Pain during the procedure Gómez 2004215Mean Difference (IV, Fixed, 95% CI)-0.43 [-1.29 to 0.43]

Appendix 11. Baseline pain: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Baseline pain Renner 2012120Mean Difference (IV, Fixed, 95% CI)-5.00 [-10.78 to 0.78]

Appendix 12. Speculum insertion: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Speculum insertion Renner 2012120Mean Difference (IV, Fixed, 95% CI)1.00 [-7.26 to 9.26]

Appendix 13. Pain during paracervical block: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Paracervical block Renner 2012120Mean Difference (IV, Fixed, 95% CI)24.00 [14.69 to 33.31]

Appendix 14. Pain during cervical dilation: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Cervical dilation Renner 2012120Mean Difference (IV, Fixed, 95% CI)-36.00 [-44.64 to -27.36]

Appendix 15. Pain during aspiration: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Aspiration Renner 2012120Mean Difference (IV, Fixed, 95% CI)-26.00 [-33.48 to -18.52]

Appendix 16. 30 minutes after the procedure: PLA versus no anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
30 min after the procedure Renner 2012120Mean Difference (IV, Fixed, 95% CI)10.00 [1.40 to 18.60]

Appendix 17. Pain during the procedure: PLA versus other regional anaesthesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Pain during the procedure Finikiotis 1992120Odds Ratio (M-H, Fixed, 95%CI)1.41 [0.68 to 2.91]
Severe pain Finikiotis 1992120Odds Ratio (M-H, Fixed, 95%CI)0.17 [0.42 to 3.27]
Moderate to severe pain Finikiotis 1992120Odds Ratio (M-H, Fixed, 95%CI)1.22 [0.80 to 1.88]

Appendix 18. Pain during anaesthetic application: PLA versus other regional anaesthesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Pain during anaesthetic application Yazaci 2003114Mean Difference (IV, Random, 95%CI)9.49 [4.20 to 14.78]

Appendix 19. Postoperative pain at difference times: PLA versus other regional anaesthesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
10 minutes Al-Sunaidi 200784Mean Difference (IV, Random, 95%CI)-0.40 [-0.51 to -0.29]
15 minutes Yazaci 2003114Mean Difference (IV, Random, 95%CI)-4.63 [-9.02 to -0.24]
30 minutes Al-Sunaidi 200784Mean Difference (IV, Random, 95%CI)-0.70 [-0.79 to -0.61]
60 minutes Al-Sunaidi 200784Mean Difference (IV, Random, 95%CI)-0.20 [-0.27 to -0.13]

Appendix 20. Adverse effects: PLA versus other regional anaesthesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Vasovagal reaction Yazaci 2003114Risk Ratio (M-H, Random, 95%CI)0.69 [0.13 to 3.82]

Appendix 21. Pain during uterine intervention: PLA versus systemic analgesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Hysteroscopic electrosurgery Guida 2003166Mean Difference (IV, Random, 95%CI)0.20 [-0.03 to 0.45]
Manual vacuum aspiration Lopez 2007113Mean Difference (IV, Random, 95%CI)0.40 [-0.82 to 1.62
Hysteroscopy and endometrial biopsy:1 Sharma 2009120Mean Difference (IV, Random, 95%CI)1.80 [1.24 to 2.36]
Hysteroscopy and endometrial biopsy:2 Sharma 2009a120Mean Difference (IV, Random, 95%CI)0.35 [-0.26 to 0.96]

Appendix 22. Pain during uterine intervention:PLA versus systemic analgesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Pain during uterine intervention Mola 199630Risk Ratio (M-H, Random, 95%CI)0.82 [0.49 to 1.37]

Appendix 23. Postoperative pain: PLA versus systemic analgesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
15 minutes Guida 2003166Mean Difference (IV, Random, 95%CI)0.10 [-0.19 to 0.39]
24 hours Guida 2003166Mean Difference (IV, Random, 95%CI)-0.20 [-0.31 to -0.09]
3 days Guida 2003166Mean Difference (IV, Random, 95%CI)0.00 [-0.03 to 0.03]

Appendix 24. Requirement for postoperative analgesia: PLA versus systemic analgesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Requirement of analgesia Guida 2003166Risk Ratio (M-H, Random, 95%CI)1.28 [0.36 to 4.60]

Appendix 25. Patient satisfaction: PLA versus systemic analgesia, single study analysis

OutcomesStudyParticipantsStatistical methodEffect estimate
Patient satisfaction Guida 2003166Risk Ratio (M-H, Random, 95%CI)0.99 [0.91 to 1.07]

Appendix 26. Operator's perception of the analgesia: PLA versus systemic analgesia, single study analysis  

OutcomesStudyParticipantsStatistical methodEffect estimate
Operator's perception Mola 199630Risk Ratio (M-H, Random, 95%CI)1.50 [0.71 to 3.16]

What's new

DateEventDescription
26 September 2013New citation required and conclusions have changed

We updated our search from January 2006 to August 2013. We included nine new studies (26 included studies in total) involving 2790 participants (Al-Sunaidi 2007; Amirian 2009; Chudnoff 2010; Lazenby 2009; Lopez 2007; Mankowski 2009; Renner 2012; Sharma 2009; Thongrong 2011). We excluded 10 new studies (Agostini 2008; Allen 2006; Allen 2009; Cansino 2009; Habersetzer 1972; Harper 1997; Karasahin 2011; Manyou 2008; Naki 2011; Phittayawechwiwat 2007).

We re-evaluated the list of excluded studies in our previously published review (Tangsiriwatthana 2009) and removed any that did not meet our inclusion criterion of randomized controlled trial (RCT). We removed 18 studies from the list of excluded studies as they were not RCTs (Amyot-Legault 1981; Coker 1968; Fernandez 1997; Ferry 1994; Formiga-Filho 1974; Gad 1967; Lewis 1971; Littlepage 1969; Readman 2004; Reguer Noriega 1973; Rotchell 1976; Sandmire 1974; Santonja 1974; Strausz 1971; Thonneau 1998; Toth 2000; Van Praagh 1967; Walden 1973).

Therefore, the total number of excluded studies in the updated review is 70 studies. Three studies are still awaiting classification (Chaudhuri 1980; Regina 1987; Sen 1980).

The nine new studies have minimally changed the review's results and conclusions.

We included risk of bias and summary of findings tables in this updated review.

26 September 2013New search has been performed

We changed some search strategies from those in the published protocol for higher sensitivity. See details in the 'Appendices'.

We used the GradeProfiler Program to grade the quality of the studies.

History

DateEventDescription
12 March 2007New citation required and conclusions have changedSubstantive amendment

Contributions of authors

Conceiving the review: Thumwadee Tangsiriwatthana (TT)

Co-ordinating the review: Ussanee Swadpanich (US)

Undertaking manual searches: TT and US

Screening search results: TT and US

Organizing retrieval of papers: TT

Screening retrieved papers against inclusion criteria: TT, US and Pisake Lumbiganon (PL)

Appraising quality of papers: TT and US

Abstracting data from papers: TT and US

Writing to authors of papers for additional information: TT

Providing additional data about papers: TT

Obtaining and screening data on unpublished studies: TT and US

Data management for the review: TT

Entering data into Review Manager (RevMan 5.1): TT

RevMan statistical data: Malinee  Laopaiboon (ML)

Other statistical analysis not using RevMan: ML

Double entry of data: (data entered by person one: TT; data entered by person two: US)

Interpretation of data: TT, US and PL

Statistical inferences: ML

Writing the review: TT, US, PL and ML

Securing funding for the review: PL

Performing previous work that was the foundation of the present study: PL

Guarantor for the review (one author): PL

Persons responsible for reading and checking review before submission: TT, US, PL and ML

Declarations of interest

Thumwadee Tangsiriwatthana: none know

Ussanee S Sangkomkamhang: none known

Pisake Lumbiganon: none known

Malinee Laopaiboon: none known

Sources of support

Internal sources

  • Medical Education Centre, Khon Kaen Regional Hospital, Thailand.

  • Khon Kaen University, Thailand.

External sources

  • Thai Cochrane Network, Thailand.

  • Thailand Research Fund (Senior Research Scholar), Thailand.

  • Cochrane Anaesthesia Review Group (CARG), Denmark.

Differences between protocol and review

In the updated review (final search run August 2013) we changed some of the search strategies from the previously published review for higher sensitivity (Tangsiriwatthana 2009). See details in the Appendices (Appendix 1, Appendix 2, Appendix 3).

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Al-Sunaidi 2007

MethodsRandomized controlled trial
ParticipantsEighty-four women who underwent outpatient hysteroscopy for evaluation of the uterine cavity
Interventions

All women received oral lorazepam 10 mg, 30 minutes before the procedure

1. Intracervical block: 2 ml of 0.5% bupivacaine hydrochloride into anterior wall of the cervix

2. Combined local and paracervical injection: 2 ml of 0.5% bupivacaine hydrochloride into lateral vaginal fornix bilaterally at the 3 and 9 o'clock positions at the depth of 10 mm (4 ml on each side)

Outcomes

Pain:

1. During the procedure

2. At 10, 30 and 60 minutes after the procedure

Funding sourceNone
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization was done using a computer-generated random table
Allocation concealment (selection bias)High riskNo
Blinding (performance bias and detection bias)
All outcomes
High riskNo
Incomplete outcome data (attrition bias)
All outcomes
High riskNo
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasUnclear riskUnclear

Amirian 2009

MethodsRandomized controlled trial
Participants150 women presenting for fractional curettage (75 in each group) who had uterine size less than 14 weeks, did not have molar pregnancy, missed abortion, underlying painful condition and no history of allergy to ibuprofen. Uterine perforation, and severe bleeding during curettage were excluded.
Interventions

All women received 400 mg oral ibuprofen 30 min before curettage

  1. PLA: 1% lidocaine

  2. Placebo: normal saline

4 ml injected at anterior or posterior part of cervix submucosa and followed by 16 ml injected at 3 and 9 o'clock of cervicovaginal reflection with depth of 1 cm

Outcomes

Pain using visual analogue scale 0 to 100 according to Likert Scale. Pain intensity were assessed in four stages:

  1. After speculum insertion

  2. During cervical dilatation

  3. During curettage

  4. 30 minutes after curettage completion

Funding sourceNo information
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSyringes were labelled with stickers pre-printed with computer-generated random numbers
Allocation concealment (selection bias)Low riskThe appearance of the syringes and solutions were identical in each group. The random-number key was not broken until data analysis
Blinding (performance bias and detection bias)
All outcomes
Low riskThe appearance of the syringes and solutions were identical in each group and the stickers were removed before the procedure
Incomplete outcome data (attrition bias)
All outcomes
High riskNo
Selective reporting (reporting bias)High riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasHigh riskExclusion criteria (uterine perforation and severe bleeding during curettage) were post-allocation complications which might affect the results, if any

Buppasiri 2005

MethodsRandomized controlled trial
Participants87 women, 40 years and over, undergoing outpatient fractional curettage for abnormal uterine bleeding (44 in PLA group and 43 in analgesia group). The authors excluded women with peptic ulcer, a known sensitivity to non-steroidal anti-inflammatory drugs, taking medications with known interactions with non-steroidal anti-inflammatories, who were sensitive to lignocaine, or unable to provide informed consent
Interventions

1. PLA: 2% lignocaine 5 ml injected into the lateral fornix at 3 and 9 o'clock at a depth of between 3 and 5 mm
Fractional curettage was performed 5 min after the paracervical injection

2. Analgesic: mefenamic acid 500 mg orally two hours before the procedure

Outcomes

Pain was evaluated using a 10 cm visual analogue scale:

  1. Before the procedure

  2. During endocervical curettage

  3. Endometrial curettage

  4. Immediately after curettage

  5. 30 minutes after completing the procedure

Adverse effects:

  1. Dizziness

Funding sourceNo information
NotesThree women in each group could not tolerate the pain and needed intravenous pethidine
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear
Allocation concealment (selection bias)Unclear riskRandomly allocated was performed but did not mentioned about concealment
Blinding (performance bias and detection bias)
All outcomes
High riskNo
Incomplete outcome data (attrition bias)
All outcomes
High riskNo
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Carroll 2005

MethodsRandomized controlled trial
Participants58 women undergoing endometrial biopsy (27 in PLA and 31 in no anaesthesia group). Women were excluded for the following reasons: allergy to lidocaine, allergy to ibuprofen, refusal to participate, additional procedure (e.g. loop electrosurgical excision procedure, colposcopy etc), or inability to speak English
Interventions
  1. PLA: 10 ml of 1% lidocaine injected paracervically at 2, 4, 8, and 10 o'clock positions and waited 3 to 5 minutes before biopsy (Pipelle biopsy)

  2. No anaesthesia

OutcomesPain immediately before the procedure, immediately after the procedure, at 5 minutes, and at 10 minutes
Funding sourceVicksburg Hospital Medical Foundation
NotesWe were unable to perform a subgroup analysis comparing cervical dilatation versus no cervical dilatation because results were not reported by intervention
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated block randomization
Allocation concealment (selection bias)Low riskOpaque sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
High riskNo
Incomplete outcome data (attrition bias)
All outcomes
Low riskOne patient was randomized, but biopsy was unable to be performed
Selective reporting (reporting bias)Unclear riskUnclear

Chanrachakul 2001

MethodsRandomized controlled trial
Participants140 women who underwent fractional curettage (70 in each of paracervical and saline groups). The exclusion criterion was an allergic reaction to lidocaine
Interventions
  1. PLA: 1% lidocaine hydrochloride

  2. Placebo: 0.9% sodium chloride

Injection was with a 23-gauge spinal needle at 3 and 9 o'clock of the cervicovaginal reflection

OutcomesPain during and after the procedure
Funding sourceNo information
Notes

Using the visual analogue scale, each woman made four assessments of intensity of pain:

  1. Pain immediately after insertion of the speculum and was for intensity of pain during insertion of the speculum

  2. Immediately after curettage and was for intensity of pain during curettage

  3. Intensity of pain immediately after curettage

  4. 30 minutes after curettage for intensity of pain at that time

The repeated injection was limited to 10 ml of 1% lidocaine
No woman asked for lidocaine during the procedure or asked to leave the study

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe randomization sequence was computer generated
Allocation concealment (selection bias)Low riskThe appearance of the syringes, and solutions was identical in each group
Blinding (performance bias and detection bias)
All outcomes
Low riskThe surgeon and assessor were blinded to the type of solution used
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Chatfield 1970

MethodsRandomized controlled trial
Participants100 consecutive women with an incomplete abortion; uterine size varied from 8 to16 weeks and in the majority the cervix was open and required no further dilatation for the evacuation procedure (50 in each: PLA and placebo group)
Interventions
  1. PLA: 0.25% bupivacaine with 1:400,000 adrenaline, 5 ml

  2. Normal saline, 5 ml

Injected through the vaginal wall of each lateral fornix, approximately 1 cm from the cervix and at eight and four o'clock, half-an-hour prior to evacuation

OutcomesPatient's impression of discomfort during evacuation
Funding sourceNo information
Notes"Promazine 25 mg and promethazine 25 mg given after the block to allay the patient's natural apprehension on entering an operating theatre and being placed in the lithotomy position awake. Analgesics were omitted from the premedication to avoid confusion in the assessment of the efficacy of the anaesthetic. The discomfort was recorded as being none, slight, moderate or severe."
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandom selection
Allocation concealment (selection bias)High riskNo
Blinding (performance bias and detection bias)
All outcomes
Low riskOne operator administered the anaesthetic and second operator performed evacuation
Incomplete outcome data (attrition bias)
All outcomes
High riskNo
Selective reporting (reporting bias)Low riskUnable to compare to protocol but appears to be free of selective reporting

Chudnoff 2010

MethodsRandomized controlled trial
ParticipantsEighty women undergoing hysteroscopic sterilization (40 in each: PLA and placebo group)
Interventions
  1. PLA: 1% lidocaine, 11 ml

  2. Placebo: normal saline 11 ml

OutcomesPain was assessed at 9 points during the procedure
Funding sourceNone
Notes

A 10-cm visual analogue scale was used for pain assessment (rate the pain on the VAS and verbally confirmed masking the VAS)

60 mg of ketorolac was intramuscularly injected in all patients before they were placed in dorsal lithotomy

Pain was assessed in each of the following steps:

  1. Intramuscular injection of 60 mg ketorolac

  2. 1 ml of study preparation injected into anterior lip of cervix

  3. Single tooth tenaculum placed on anterior lip of cervix

  4. 5 ml of study preparation injected in right paracervical region at four o'clock

  5. 5 ml of study preparation injected in left paracervical region at eight o'clock

  6. Introduction of hysteroscope in external os of cervix

  7. Introduction of hysteroscope to uterine cavity through internal os

  8. Placement of left tubal insert

  9. Placement of right tubal insert

  10. 5 min after the procedure

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe vial contents were randomized using block randomization scheme with five per block
Allocation concealment (selection bias)Low riskAll vials were identical in appearance, prepared by pharmacy in a blinded fashion and delivered to the office in sealed brown bags
Blinding (performance bias and detection bias)
All outcomes
Low riskAll vials were identical in appearance, prepared by pharmacy in a blinded fashion. All participants and investigators were blinded to randomization assignments
Incomplete outcome data (attrition bias)
All outcomes
High riskNo
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Cicinelli 1998

MethodsRandomized controlled trial
Participants72 postmenopausal women undergoing diagnostic hysteroscopy and endometrial biopsy for uterine bleeding. All women had been amenorrhoeic and free of oestrogen replacement for at least one year
Interventions
  1. PLA: 10 ml of 1.5% mepivacaine

  2. Placebo: 10 ml of saline

Injected at the junction of the cervix and vagina at the 4 and 8 o'clock position

OutcomesPain
Vasovagal reactions
Funding sourceNone
NotesVisual analogue scale contained a 20-cm scale for the patient to record responses as follows: 0 cm, no pain; 5 cm, low pain; 10 cm, moderate pain; 15 cm, severe pain; and 20 cm, excruciating pain
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated block randomization numbers
Allocation concealment (selection bias)Low risk"Sealed envelopes containing computer-generated block randomization numbers"
Blinding (performance bias and detection bias)
All outcomes
Low riskBlinding participants and surgeon
Incomplete outcome data (attrition bias)
All outcomes
High riskData not presented
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Egziabher 2002

MethodsRandomized controlled trial
Participants142 women with incomplete abortion underwent manual vacuum aspiration. Inclusion criteria: less than 16 weeks of gestation. Exclusion criteria: evidence of infections, blood pressure more than 140/90 mm Hg, diabetes, cardiac diseases, severe anaemia, cervix less than 1.5-2 cm dilated, allergy to lidocaine, respiratory distress and acute pelvic inflammatory disease
Interventions
  1. PLA: 1% lidocaine

  2. Placebo: sterile water

Injected about 2 ml of lidocaine or placebo just under the epithelium not deeper than 2-3 mm at 3 and 9 o'clock

OutcomesPain
Side effects: abdominal pain, shoulder tip pain, and backache
Funding sourceNone
NotesWe analysed data during and after the procedure only, not data before the procedure
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Selected women using random tables"
Allocation concealment (selection bias)Unclear riskUnclear
Blinding (performance bias and detection bias)
All outcomes
Low riskThe investigator, participant and nurse filling out the questionnaire were blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Finikiotis 1992

MethodsControlled clinical trial
Participants120 women who were referred from general practitioners and other gynaecologists for the investigation of a variety of gynaecological complaints and underwent outpatient hysteroscopy
Interventions
  1. PLA: 16-20 ml of 1% lidocaine using a paracervical block after a small amount (<0.5 ml) was injected into the anterior lip of the cervix for placement of a tenaculum

  2. USB: 2ml of 2% lidocaine with 1:80,000 adrenaline into each uterosacral ligament. A small amount (<0.5 ml) was injected into the anterior lip of the cervix which was then grasped with a tenaculum

OutcomesPain
Funding sourceNo information
NotesWe used the cut-off point at 0-3.3 = no pain and 3.4 to 10 = pain
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskRandomized using even or odd units record numbers
Allocation concealment (selection bias)High riskNo allocation concealment
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnclear
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasLow risk 

Glantz 2001

MethodsRandomized controlled trial
Participants79 pregnant women at least 18 years old, between 7 and 12 weeks' gestation, undergoing elective termination of pregnancy by mechanical aspiration. Women were excluded if they had significant medical complications that put them at risk for complications in the clinic setting, or if they had a history or sensitivity to local anaesthetic
Interventions
  1. PLA: 10 ml of 1% chloroprocaine

  2. Placebo: 10 ml of saline

  • Group A: 3-5-7-9 o'clock (5-2-2-5 ml, 1% chloroprocaine)

  • Group B: 4-8 o'clock (7-7 ml, 1% chloroprocaine)

  • Group C: 3-5-7-9 o'clock (5-2-2-5 ml, normal saline)

  • Group D: 4-8 o'clock (7-7 ml, normal saline)

The day before the procedure, a nurse practitioner inserted one laminaria into the cervical canal, women took 600 mg of ibuprofen 1 hour before aspiration. The laminaria were removed on the day of the termination procedure

OutcomesPain immediately following paracervical block administration, after aspiration, and arrival in the recovery room
Funding sourceNo information
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization block of four was used with block randomly ordered by use of random-number table
Allocation concealment (selection bias)Low riskOrdered opaque sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
Low riskThe doctor and assisting nurse
Incomplete outcome data (attrition bias)
All outcomes
High riskTwo decided not to participate in the study after randomization and one was withdrawn after the randomized paracervical technique was administered, these patients were not included in the analysis
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Guida 2003

MethodsRandomized controlled trial
Participants166 women with surgically treatable lesions associated with infertility or abnormal uterine bleeding (82 in the PLA group and 84 in the SA group). Exclusion criteria were menopausal women (FSH > 40 mIU/ml, 17 beta-estradiol < 20 pg/ml), and/or pregnancy (positive beta-hCG test), and a history of anaesthetic or surgical complications
Interventions
  1. PLA: 10 ml of 1% mepivacaine hydrochloride injected with 22-gauge spinal needle at four sites (3, 5, 7 and 9 o'clock positions) at the junction of the cervix and vagina

  2. SA: 0.5 mg of atropine, 0.25 mg of fentanyl, followed by an intravenous slow injection of 2.0 mg of midazolam

Outcomes

Pain

Adverse effect:

  1. Pallor or hypotension

  2. Nausea and vomiting

Patient satisfaction

Funding sourceSurgical equipment was provided by Gynecare Italia (Gynecare S.p.A., Pomezia, Italy)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomization list in block of two
Allocation concealment (selection bias)Unclear riskUnclear
Blinding (performance bias and detection bias)
All outcomes
High riskTwo difference interventions cannot be blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasUnclear riskNo information on funding

Gómez 2004

MethodsRandomized controlled trial
Participants215 women who were at 12 weeks of gestation or less with incomplete abortion (107 in no anaesthesia group and 108 in paracervical group). Women with active infections, severe illness, psychiatric disorders, or allergies to lidocaine were excluded
Interventions
  1. PLA: Psychological support and paracervical block using 1.0% lidocaine 5 ml injected slowly to a depth of 0.5 cm in the cervix-vaginal joint at 4 or 5 or 7 or 8 o'clock positions

  2. Psychological support but no paracervical block

OutcomesIntraoperative pain
Changes in the level of pain: before and during the procedure
The need to suspend the procedure or administer anaesthetics or parenteral sedatives; the need for other parenteral analgesics
Existence of intraoperative and postoperative complications
Funding sourceDavid and Lucille Packard Foundation
NotesWe analysed pain and administered anaesthetic medicaments or parenteral sedatives
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated of random number table using block of 2, 4,and 6 to generate the list of treatment allocation
Allocation concealment (selection bias)Low risk"Sealed sequential opaque envelopes"
Blinding (performance bias and detection bias)
All outcomes
Low riskThe trained observer was blinded to the woman's group assignment
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Kan 2004

MethodsRandomized controlled trial
Participants134 women attending for suction termination of pregnancy under local anaesthesia: age over 16 years, normal general and gynaecological examination, up to 12-weeks gestation on the day of recruitment and size of the uterus on pelvic examination compatible with estimated duration of pregnancy. Exclusions: allergy to lidocaine, history of severe respiratory or cardiac disease, severe and recurrent liver disease, myasthenia gravis, psychiatric conditions requiring medication, contraindications to prostaglandins use
Interventions
  1. PLA: 10 ml of 1% lidocaine injected at the vaginal vault

  2. Intracervical: 10 ml of 1% lidocaine injected at the cervix 2.5 cm beneath the mucosa

  3. No local injection

All women received conscious sedation 2 mg midazolam and 25 mcg fentanyl

Outcomes

Pain before the operation, just after the operation, and 1 hour after suction evacuation
Need for additional analgesia
Adverse effects

Patients' satisfaction

Funding sourceHong Kong Obstetrical and Gynaecological Trust Fund
NotesWe compared both interventions; PLA versus intracervical injection and PLA versus no local injection
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization list generated by computer with sequentially number envelopes with a block size of nine
Allocation concealment (selection bias)Low riskAn opaque, sequentially numbered envelope containing the allocated intervention was attached to the patient's record, and was opened by the surgeon in the operation theatre
Blinding (performance bias and detection bias)
All outcomes
Low riskBoth participant and assessor were blinded to the technique of paracervical block
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasLow risk 

Lau 1999

MethodsRandomized controlled trial
Participants99 women undergoing outpatient hysteroscopy and endometrial biopsy for abnormal uterine bleeding
Interventions
  1. PLA: 10 ml of 2% lidocaine

  2. Placebo: 10 ml of normal saline

Paracervical block was performed using a 22-gauge spinal needle and the solution was given at 3, 5, 7, and 9 o'clock of the paracervical region in divided doses

Outcomes

Pain felt at different stages of the procedure

Vasovagal reaction

Funding sourceNo information
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated block number put inside a sealed envelope
Allocation concealment (selection bias)Low riskNumber put inside sealed envelope
Blinding (performance bias and detection bias)
All outcomes
Low riskThe attending doctor, nurse staff and the woman were all blinded to the identity of the medication used
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Lazenby 2009

MethodsRandomized controlled trial
Participants72 women undergoing abortion under general anaesthesia, age 18-40 years old, gestational age between 5 to 20 weeks. Patients were excluded if allergic to bupivacaine, known uterine anomaly, psychiatric illness, myasthenia gravis or any other severe medical condition
Interventions
  1. PLA: 10 ml of 0.5% Marcaine was injected after induction of anaesthesia and prior to the procedure

  2. No local anaesthesia

Outcomes

-Pain at awaking from anaesthesia, 30 minutes after the procedure, 60 minutes after the procedure and prior to discharge

-Additional drug requirement

Funding sourceDepartment of Obstetrics and Gynecology at the University of Hawaii John A Burns School of Medicine
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomization by randomly selecting the envelope. Information about sequence generation was unclear
Allocation concealment (selection bias)Low riskUsing unmarked opaque mailing envelope from a bin
Blinding (performance bias and detection bias)
All outcomes
Low riskSingle-blinded (patient), and patients themselves evaluated their pain level
Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 37 of the 39 enrolled participants in PLA group were analysed in comparison of mean pain scores
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasLow risk 

Lopez 2007

MethodsRandomized controlled trial
Participants113 women diagnosed with incomplete abortion and underwent manual vacuum aspiration
Interventions
  1. PLA + diclofenac

  2. Meperidine + diclofenac

  3. Meperidine alone

OutcomesPain levels using Wong Scale of Pain
Funding sourceNo information
NotesWe only analysed the comparison between PLA + diclofenac to meperidine + diclofenac in order to avoid the effect of diclofenac combined with PLA
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom table generated by a computational algorithm based on a block size of nine
Allocation concealment (selection bias)Low riskThe randomization distribution was kept in sealed, sequential, opaque envelopes
Blinding (performance bias and detection bias)
All outcomes
High riskThree difference interventions cannot be blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting
Other biasLow risk 

Mankowski 2009

MethodsRandomized controlled trial
Participants132 participants who undergoing elective first-trimester suction curettage with conscious sedation. Exclusion criteria were gestation more than 12 weeks by ultrasonography, weight less than 98 pounds, allergy to lidocaine, or known non-viable pregnancy
Interventions
  1. PLA: 20 ml of 1% lidocaine injected around cervicovaginal junction at 3, 5, 7,and 9 o'clock with 5/8 inch depth

  2. Intracervical block: 20 ml of 1% lidocaine injected into the cervical stroma at 12, 3, 6, and 9 o'clock at the depth of 1 inch

OutcomesPain at 3 three time points: at baseline (before sedation), at completion of dilation, and at completion of curettage
Funding sourceNone
NotesAll participants received preoperative protocol consisted of 800 mg of oral ibuprofen and intravenous sedation consisting of 1 mg midazolam and 100 micrograms fentanyl immediately before the procedure
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomization in blocks of 10 using a random-numbers table, sequentially numbered were prepared ahead of time
Allocation concealment (selection bias)Low riskOpaque sealed envelopes containing a description of the assigned block was used. The random allocation sequence remained concealed until data analysis
Blinding (performance bias and detection bias)
All outcomes
Low riskBoth the participants and surgical assistants administering the pain scales were blinded to study assignment
Incomplete outcome data (attrition bias)
All outcomes
Low riskSix participants had incomplete pain scores, one in PLA groups and five in intracervical group; three patients were missing VAS scores at dilation, two at curettage and one missing both scores.
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Miller 1996

MethodsRandomized controlled trial
Participants52 women presenting for pregnancy termination (27 in PLA group and 25 in placebo group). Exclusion criteria: did not speak English, allergy to lidocaine, had used cocaine within 24 hours, or were greater than 14 weeks' gestation as estimated by ultrasound measurements
Interventions
  1. PLA: 20 ml of 1% lidocaine

  2. Placebo: 20 ml of 0.9% sodium chloride

* I.V. 50 microgram fentanyl given before procedure if requested

OutcomesPain: after speculum placement, after cervical canal dilation and/or insertion of the cannula, after aspiration, and then 30 minutes after the procedure
Vasovagal reactions
Funding sourceNo information
NotesBlock was repeated on request by one woman who found dilatation painful
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear
Allocation concealment (selection bias)Unclear risk"All study syringes were made up at the beginning of each clinic session and labelled with random five-digit numbers. Syringes were then mixed in a draw and withdraw one at a time"
Blinding (performance bias and detection bias)
All outcomes
Low riskThe number sticker was taken off the syringes at the time of the procedure. The random-number key was not broken until data analysis
Incomplete outcome data (attrition bias)
All outcomes
Low riskEight eligible subjects refused to provide basic demographic data, 83 refused to be randomized to drug comparison
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Mola 1996

MethodsRandomized controlled trial
Participants30 women undergoing bi-manual removal of retained placentas
Interventions
  1. PLA: women 40-59 kg received 20 ml, 60-79 kg received 32 ml and weighing > 79 kg received 40 ml of 0.5% lidocaine, respectively [these women received premedication - see notes]

  2. Diazepam and pethidine group: women 40-59 kg received pethidine 50 mg and diazepam 5 mg, women 60-79 kg received pethidine 75 mg and diazepam 7.5 mg, and weighing > 79 kg received pethidine 100 mg and diazepam 10 mg, respectively

Outcomes

Participants' perception of pain experienced during the procedure

The operator's perception of the participants' pain and the difficulty of the placental removal

Immediate and late complications

Funding sourceNo information
NotesBoth groups were premedicated with intravenous pethidine 0.5 mg/kg and diazepam 1 mg/10 kg between 30 and 60 minutes before the procedure
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear
Allocation concealment (selection bias)Low risk"Sealed envelopes" were used
Blinding (performance bias and detection bias)
All outcomes
High riskTwo difference interventions cannot be blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnclear
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Renner 2012

MethodsRandomized controlled trial
Participants120 women undergoing abortion receiving paracervical block or sham stratified by gestational age (early: less than 8 weeks of gestation, n60; late: 8–10 6/7 weeks of gestation, n60). Inclusion criteria included: age older than 18 years, good general health, and English-speaking or Spanish-speaking. Women were excluded if they did not meet inclusion criteria, requested intravenous sedation, which would have possibly blunted the effect of the paracervical block, or were unable or unwilling to receive ibuprofen, lorazepam, paracervical block, or all of these. Women with gestations of 11 weeks and above were also excluded
Interventions
  1. PLA: 20 mL 1% buffered lidocaine, 2 mL injected at the tenaculum site,12 o’clock superficially into the cervix. The remaining 18 mL are injected slowly over 60 seconds into the cervicovaginal junction in four equal aliquots at 2, 4, 8, and 10 o’clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)

  2. Sham: 20 mL 1% buffered lidocaine, 2 mL injected at the tenaculum site,12 o’clock superficially into the cervix. Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o’clock

OutcomesPrimary outcome: dilation pain (100 mm visual analogue scale)
Secondary outcomes: pain at additional time points, satisfaction, need for more analgesics, and adverse events
Funding sourceNo information
NotesAll participants were premedicated with 800 mg oral ibuprofen and 2 mg oral lorazepam at least 30 minutes before the procedure
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization was computer-generated (block size six; generated by study staff not involved in enrolment of participants) and stratified by gestational age less than 8 weeks (early) or 8–10 6/7 weeks (late)
Allocation concealment (selection bias)Low riskAllocation concealment was ensured using sequentially numbered opaque, sealed envelopes, opened only after the patient was put in a room for her procedure
Blinding (performance bias and detection bias)
All outcomes
Low riskEveryone in the room (woman, advocate, assistant) except for the surgeon was blinded to the technique
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)High riskmost women in the study were able to identify the treatment group to which they were randomized

Sharma 2009

MethodsRandomized controlled trial
Participants120 women undergoing hysteroscopy and endometrial biopsy (40 women in each group). Pregnant women, known sensitivity to non-steroidal anti-inflammatory drugs or lignocaine, unable or unwilling to provide informed consent and having history of cervical surgery were excluded from the study
Interventions
  1. Fixed dose drotaverine (80 mg) with mefenamic acid (250 mg)

  2. PLA: 10 ml of 10% lignocaine solution

  3. Diazepam (0.2 mg/kg) and pentazocine (0.6 mg/kg)

OutcomesPain score during the procedure, at 30 and 60 minutes
Funding sourceMartin and Harris Private Ltd. India (drugs supply)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomized using computer-generated randomization
Allocation concealment (selection bias)High riskOpen-label randomized trial
Blinding (performance bias and detection bias)
All outcomes
High riskThree difference intervention cannot be blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Thongrong 2011

MethodsRandomized controlled trial
Participants64 women with abnormal uterine bleeding and had indication for curettage. Exclusion criteria were abnormal uterine bleeding from coagulopathy, active liver or kidney disease, history of lidocaine or morphine allergy, and had pain relief by other anaesthetic drug or technique before curettage
Interventions
  1. PLA: 20 ml of 1% lidocaine injected at 3 and 9 o’clock of cervicovaginal reflection at an estimated depth of 1 cm by marker knot on the needle inserter

  2. Intravenous morphine: 8 mg of morphine diluted in sterile water 10 ml was administered intravenously 5 minutes before uterine curettage

OutcomesPain scores during and after uterine curettage
Funding sourceNo information
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskSimple randomization was performed
Allocation concealment (selection bias)High riskThe allocation concealment was not mentioned
Blinding (performance bias and detection bias)
All outcomes
High riskThe participant, the gynaecologist performing the operation and nurse assistant knew the type of drug administered
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Titapant 2003

MethodsRandomized controlled trial
Participants70 women with unknown cause of abnormal vaginal bleeding who underwent fractional curettage (35 in PLA group and 35 in placebo group). All women were healthy, except for their bleeding, did not have diabetes mellitus or hypertension. Women who had abnormal coagulation or a history of chronic pelvic pain were excluded
Interventions
  1. PLA: 1% xylocaine without adrenaline

  2. Placebo group: normal saline

Infiltrated around cervix just before the procedure was performed

OutcomesPain during the procedure and 30 minutes afterwards
Funding sourceNo information
Notes

No explanation of what pain scale was - what was the smallest and largest possible numerical values and what did they mean?

We analysed pain during endometrial curettage only, not during endocervical curettage

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear
Allocation concealment (selection bias)Unclear riskUnclear
Blinding (performance bias and detection bias)
All outcomes
Low riskIdentical appearance and quantity of solution, patients themselves (blinded) reported their pain level
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Vercellini 1994

MethodsRandomized controlled trial
Participants177 women with excessive uterine bleeding for at least 3 months. Excluded: pregnancy, menopausal (FSH >29 mIU/mL), genital infections, previous cervical surgery or hysteroscopy, severe cardiac disease, sensitivity to local anaesthetic
Interventions
  1. PLA: 10 ml of 1% mepivacaine hydrochloride solution injected with a 22-gauge spinal needle at four sites at 3, 5, 7, and 9 o'clock positions at the junction of the cervix and vagina

  2. No anaesthesia

OutcomesLower abdominal and pelvic pain at hysterectomy and endometrial biopsy
Funding sourceNo information
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUsing randomization lists
Allocation concealment (selection bias)High riskOpen-label randomized trial
Blinding (performance bias and detection bias)
All outcomes
High riskComparing between treatment and no treatment
Incomplete outcome data (attrition bias)
All outcomes
Low riskThe procedure could not be performed in four participants (2 of each) and were excluded from the study
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Yazaci 2003

  1. a

    PLA = Paracervical local anaesthesia
    GA = General anaesthesia
    SA = Systemic analgesia
    D & C = Dilatation and curettage
    GA = General anaesthesia
    CVS = Cardiovascular system
    RS = Respiratory system
    ml = millilitre
    mg = milligram
    mcg = microgram
    i.v. = intravenous
    kg = kilogram
    sec = second
    USB = Uterosacral block

MethodsRandomized controlled trial
Participants114 woman undergoing endometrial biopsy for abnormal uterine bleeding. All women were multiparous without history of allergy to lidocaine or any other medication. Women suspected to be pregnant were excluded
Interventions

Women were randomly assigned into four groups:

  • Group A: (Placebo group): intrauterine instillation of 2 ml of 0.9% saline solution

  • Group B: intrauterine instillation of 2 ml of 20 mg/ml lidocaine hydrochloride

  • Group C: paracervical injection of 1% lidocaine (volume unclear)

  • Group D: intrauterine instillation of 2 ml of 20 mg/ml lidocaine hydrochloride and paracervical injection of 1% lidocaine (volume unclear)

Outcomes

Pain: during the application of the anaesthetic; during cervical dilation; during endometrial biopsy; 15 minutes after the procedure

Adverse effects

Funding sourceNo information
NotesWe compared PLA alone (group C) with intrauterine instillation of lidocaine (group B)
We also analysed data comparing with and without cervical dilatation among groups
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear
Allocation concealment (selection bias)Unclear riskUnclear
Blinding (performance bias and detection bias)
All outcomes
High riskFour difference intervention could not be blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up: adequate
Selective reporting (reporting bias)Low riskYes. Unable to compare to protocol but appears to be free of selective reporting

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Agostini 2003The intervention of this study was performed using neither anaesthesia nor analgesia
Agostini 2008All women received paracervical block with different anaesthetic agents (ropivacaine and lidocaine. No comparison between paracervical block and other anaesthesia
Allen 2006This study was not a randomized controlled study and all women received paracervical block as adjunct with and without lorazepam or intravenous sedation. No direct comparison between procedures
Allen 2009All women tested all-in-one paracervical block with or oral or intravenous sedation. No direct comparison between procedures
Bain 2001The intervention for this study was intracervical not paracervical block
Baskett 1974This study was excluded because a comparison between different strengths of bupivacaine. No direct comparison between procedures
Bradley 1995The intervention of this study was performed under neither anaesthesia nor analgesia
Broadbent 1992The intervention for this study was intracervical not paracervical block
Canni 2001All women received paracervical block. No comparison between paracervical block and other anaesthesia but evaluated the role of periorificial infiltration of local anaesthetic
Cansino 2009All women received paracervical block in combination with lidocaine alone or lidocaine with ketorolac. No comparison between paracervical block and other anaesthesia
Cetin 1997All women received paracervical block and assessed the effect of deep or regular injection of local anaesthetics
Chen 1994This study was excluded because the intervention was not cervical dilatation or uterine intervention
Duggan 1999All women tested all-in-one paracervical block and intravenous sedation. No direct comparison between procedures
Duncan 2005The intervention of this study was not cervical dilatation and uterine intervention but colposcopically directed biopsy and anaesthetic or placebo was injected into the biopsy site and treatment with coagulator, not paracervical block
Edelman 2004All women received paracervical block and compared between intrauterine lidocaine and saline infusion to study the effects on perceived participant pain
Esteve 2002The intervention for this study is intracervical not paracervical block
Grimes 1979This study was excluded because no clinically relevant outcomes (pain or nausea and vomiting) were reported. There were only operative complications (uterine haemorrhage, uterine perforation, intra-abdominal haemorrhage, cervical injury, fever, blood transfusion, cervical suture, laparotomy, hysterotomy or hysterectomy) shown
Guasch 2005This study was excluded because no clinically relevant outcomes were reported and the objective of the study was to compare the prolactin and stress hormone response to surgical stimulus under various anaesthetic techniques
Gudgeon 1968This study was excluded because comparison between different strengths of bupivacaine. No direct comparison between procedures
Habersetzer 1972This study was a case series, no comparison group
Harper 1994This study was excluded because the intervention was not cervical dilatation and uterine intervention with comparison between paracervical and intracervical block
Harper 1997This study was excluded because the intervention was not cervical dilatation and uterine intervention with comparison between paracervical and intracervical block
Harper 1998This study was excluded because the intervention was not cervical dilatation or uterine intervention
Hasham 1993This study was excluded because performed paracervical block following ablation of the endometrium
Hedberg 1966This study was a case series, no comparison group
Jensen 1984This study was excluded because the intervention was in the first stage of labour without uterine intervention
Johnson 1989This study was excluded because the intervention was not cervical dilatation or uterine intervention
Johnson 1996This study was excluded because the intervention was not cervical dilatation or uterine intervention
Kamat 1979This study compared paracervical and pericervical block. No direct comparison between paracervical block and other anaesthesia
Karasahin 2011This study compared the effectiveness of lidocaine spray and placebo in addition to paracervical block. No direct comparison between paracervical block and other anaesthesia
Kaya 2004All women tested all-in-one paracervical block and intravenous sedation. No direct comparison between procedures
Kun 1999The intervention for this study was intracervical not paracervical block
Lee 1986This study was excluded because the intervention was not cervical dilatation or uterine intervention
Lee 1998This study was excluded because the intervention was not cervical dilatation or uterine intervention
Longhi 1996This study was excluded because a non-randomized controlled study and all women received paracervical and pudendal block
Mackay 1985This study was excluded because no clinically relevant outcomes (pain, nausea and vomiting) were reported. There were only operative complication (uterine haemorrhage, uterine perforation, intra-abdominal haemorrhage, cervical injury, fever, blood transfusion, cervical suture, laparotomy, hysterotomy or reported (fever, blood transfusion, unintended abdominal surgery, retained products of conception, postoperative haemorrhage, repeat curettage)
Makris 2001The procedure in this study was performed without any kind of anaesthesia
Manyou 2008All women tested all-in-one paracervical block and oral analgesic or placebo. No direct comparison between procedures
Mckenzie 1978All women received paracervical block using modified jet injector compare with standard syringe and needle technique. No comparison between paracervical block and other anaesthesia
Mercorio 2002The intervention for this study was intracervical not paracervical block
Moller 1978This study was excluded because no clinically relevant outcomes (pain, nausea and vomiting) were reported
Naki 2011The anaesthesia was not paracervical block but local injection at biopsy site
Nielsen 1975All women tested all-in-one paracervical block and intravenous sedation. No direct comparison between procedures
Nielsen 1988This study had many different co-interventions in each group, not comparing PLA alone with other anaesthesia
O'Neal 2003This study was excluded because the intervention was not cervical dilatation or uterine intervention
Owalabi 2005The intervention for this study not paracervical block alone but combined intracervical block
Oyama 2003The intervention of this study was not cervical dilatation and uterine intervention but colposcopically directed biopsy and lidocaine was injected into the biopsy site, not paracervical block
Peretz 1982This study was not a randomized controlled study
Peters 1978This study was excluded because a comparison between intracervical and paracervical block
Phair 2002All women received paracervical block and assessed the effect on pain of waiting between injection and procedure
Phittayawechwiwat 2007All women tested all-in-one paracervical block and oral analgesia or placebo. No direct comparison between procedures
Picton 1968This study was excluded because a comparison between different strengths of bupivacaine. No direct comparison between procedures
Prest 1976This study was not a randomized controlled study
Raeder 1992This study had many different co-interventions in each group, not comparing PLA alone with other anaesthesia
Ragab 1978This study was excluded because no clinically relevant outcomes
Rattanachaiyanont 2005All women received paracervical block and compared between intrauterine lidocaine and saline infusion to study the effectiveness of intrauterine anaesthesia for pain relief
Rogstad 1992This study was excluded because the intervention was not cervical dilatation or uterine intervention
Ruoss 1968This study was excluded because a comparison between different strengths of bupivacaine. No direct comparison between procedures
Sammarco 1993This study was excluded because the intervention was not cervical dilatation and uterine intervention
Scott 1968This study was excluded because a comparison between different strengths of bupivacaine. No direct comparison between procedures
Shapiro 1975All women tested all-in-one paracervical block and other sedation or stereophonic headphones. No direct comparison between procedures
Stefanidis 1998This study was excluded because the intervention was not cervical dilatation or uterine intervention
Stuart 1993This study was excluded because the intervention was not cervical dilatation or uterine intervention
Teramo 1975This study was excluded because a comparison between different strengths of etidocaine. No direct comparison between procedures
Wallage 2003The intervention for the study not paracervical block alone but combined with intracervical block
Whitehouse 1968This study was excluded because a comparison between different strengths of bupivacaine. No direct comparison between procedures
Wiebe 2005All women tested all-in-one paracervical block and intravenous sedation. No direct comparison between procedures
Willdeck 1975This study was excluded because no direct comparison between the procedure but compared different strengths of etidocaine
Winkler 1997This study was excluded because no clinically relevant outcomes
Wong 2002All women received paracervical block and conscious sedation. No comparison between paracervical block but evaluated the role of conscious sedation

Characteristics of studies awaiting assessment [ordered by study ID]

Chaudhuri 1980

MethodsNot yet assessment
ParticipantsNot yet assessment
InterventionsNot yet assessment
OutcomesNot yet assessment
NotesCARG TSC is unable to find the paper in full. The TSC is approaching other sources for the full paper

Regina 1987

MethodsNot yet assessment
ParticipantsNot yet assessment
InterventionsNot yet assessment
OutcomesNot yet assessment
NotesCARG TSC is unable to find the paper in full. The TSC is approaching other sources for the full paper

Sen 1980

  1. a

    TSC = Trials Search Co-ordinator

MethodsNot yet assessment
ParticipantsNot yet assessment
InterventionsNot yet assessment
OutcomesNot yet assessment
NotesCARG TSC is unable to find the paper in full. The TSC is approaching other sources for the full paper

Ancillary