Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery

  • Review
  • Intervention

Authors


Abstract

Background

Postoperative pain may lead to adverse effects on the body, which might result in an increase in morbidity. Its management therefore poses a unique challenge for the clinician. Major shoulder surgery is associated with severe postoperative pain, and different modalities are available to manage such pain, including opioid and non-opioid analgesics, local anaesthetics infiltrated into and around the shoulder joint and regional anaesthesia. All of these techniques, alone or in combination, have been used to treat the postoperative pain of major shoulder surgery but with varying success.

Objectives

The objective of this review was to compare the analgesic efficacy of continuous interscalene brachial plexus block (ISBPB) with parenteral opioid analgesia for pain relief after major shoulder surgery.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12), MEDLINE (1950 to December 2012), EMBASE (1980 to December 2012), Web of Science (1954 to December 2012), CINAHL (1982 to December 2012) and bibliographies of published studies.

Selection criteria

We included randomized controlled trials assessing the effectiveness of continuous ISBPB compared with different forms of parenteral opioid analgesia in relieving pain in adult participants undergoing elective major shoulder surgery.

Data collection and analysis

Two review authors independently assessed trial quality and extracted outcome data.

Main results

We included two randomized controlled trials (147 participants). A total of 17 participants were excluded from one trial because of complications related to continuous ISBPB (16) or parenteral opioid analgesia (one). Thus we have information on 130 participants (66 in the continuous ISBPB group and 64 in the parenteral opioid group). The studies were clinically heterogeneous. No meta-analysis was undertaken. However, results of the two included studies showed better pain relief with continuous ISBPB following major shoulder surgery and a lower incidence of complications when interscalene block is performed under ultrasound guidance rather than without it.

Authors' conclusions

Because of the small number of studies (two) relevant to the subject and the high risk of bias of the selected studies, no reasonable conclusion can be drawn.

Résumé scientifique

Bloc continu du plexus brachial par voie interscalénique versus analgésie par voie parentérale dans le soulagement de la douleur postopératoire après la chirurgie majeure de l'épaule

Contexte

La douleur postopératoire peut occasionner des effets indésirables sur l'organisme pouvant entraîner une augmentation de la morbidité. Par conséquent, sa prise en charge constitue un défi unique pour le clinicien. La chirurgie majeure de l'épaule est associée à une douleur postopératoire sévère, pour la prise en charge de laquelle différentes modalités sont disponibles, comme les analgésiques opiacés et non opiacés, les anesthésiques locaux infiltrés dans et autour de l'articulation de l'épaule, ou l'anesthésie locorégionale. Toutes ces techniques, seules ou en association, ont été utilisées pour traiter la douleur postopératoire de la chirurgie majeure de l'épaule, mais avec des degrés variables de succès.

Objectifs

L'objectif de cette revue était de comparer l'efficacité analgésique d'un bloc interscalénique du plexus brachial (BISPB) en continu par rapport à l'analgésie par opiacés parentéraux dans le soulagement de la douleur après la chirurgie majeure de l'épaule.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre Cochrane des essais contrôlés (CENTRAL) (2012, numéro 12), MEDLINE (de 1950 à décembre 2012), EMBASE (de 1980 à décembre 2012), Web of Science (de 1954 à décembre 2012), CINAHL (de 1982 à décembre 2012) et les bibliographies des études publiées.

Critères de sélection

Nous avons inclus les essais contrôlés randomisés évaluant l'efficacité du BISPB en continu par rapport à différents types d'analgésie par opiacés parentéraux dans le soulagement de la douleur chez des participants adultes subissant une chirurgie élective majeure de l'épaule.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment évalué la qualité des essais et extrait les données de résultat.

Résultats principaux

Nous avons inclus deux essais contrôlés randomisés (147 participants). Un total de 17 participants ont été exclus d'un essai en raison de complications liées au BISPB en continu (16) ou à l'analgésie par opiacés parentéraux (un participant). Ainsi, nous disposons d'informations sur 130 participants (66 dans le groupe BISPB en continu et 64 dans le groupe des opiacés parentéraux). Les études étaient cliniquement hétérogènes et aucune méta-analyse n'a été réalisée. Cependant, les résultats des deux études incluses montraient un meilleur soulagement de la douleur avec le BISPB en continu après la chirurgie majeure de l'épaule et une incidence plus faible de complications lorsque le bloc interscalénique était réalisé sous guidage échographique plutôt que sans lui.

Conclusions des auteurs

En raison du petit nombre d'études (deux) portant sur le sujet et le risque élevé de biais des études sélectionnées, aucune conclusion raisonnable ne peut en être tirée.

Plain language summary

Comparison of an upper limb nerve block using local anaesthetic with opioid analgesia for pain relief following major shoulder surgery

Pain following surgical procedures can sometimes increase the incidence of complications in the body. It is important to manage this pain effectively. Major shoulder surgery can cause severe pain. Effectively treating this pain will help reduce complications and will promote early mobilization. A wide range of methods are used to treat pain after major shoulder surgery, including administration of opioid (derived from opium) and non-opioid pain killers and administration of drugs that produce numbness and hence pain relief in and around the shoulder joint or around the nerves supplying the upper limb. We compared the usefulness of a continuous upper limb nerve block performed by injecting local anaesthetic into the neck close to where the nerves originate (interscalene brachial plexus block—ISBPB group) with the administration of opioid pain killers into a vein, into a muscle or under the skin (any route other than by mouth)—the parenteral opioid group.

Evidence obtained is current to December 2012. We included two studies involving 147 participants. Seventeen participants were excluded (16 from the ISBPB group and one from the other), leaving 130 participants: 66 in the ISBPB group and 64 in the parenteral opioid group. The studies were of medium to low quality because of issues with study design, and one of the trials was sponsored by a drug company.

The severity of pain was assessed by the patient using a numerical scale on which zero was considered as no pain and 10 or 100 as the worst imaginable pain for 72 hours in one study and 48 hours in the other. The severity of postoperative pain was significantly less for the ISBPB group at all time points in one study and at all but one time point in the other study.

No concrete conclusions can be drawn because of the small number of studies, which were not of high quality. However, from the available evidence, it can be seen that in one of the trials, the requirement for additional painkiller (piritramide) was significantly higher in the parenteral opioid group, whereas the other trial did not mention this. The incidence of nausea and vomiting was significantly less in the ISBPB group when compared with the parenteral opioid group. Complications related to ISBPB were virtually eliminated when ultrasound was used to perform ISBPB.

Résumé simplifié

Comparaison d'un bloc nerveux du membre supérieur à l'aide d'un anesthésique local par rapport à une analgésie aux opiacés dans le soulagement de la douleur après la chirurgie majeure de l'épaule

La douleur ressentie après l'intervention chirurgicale peut parfois augmenter l'incidence de complications dans l'organisme. Il est important de prendre en charge cette douleur efficacement. La chirurgie majeure de l'épaule peut occasionner des douleurs sévères, dont le traitement efficace permettra de réduire les complications et favoriser la mobilisation précoce. Un large éventail de méthodes sont utilisées pour traiter la douleur après la chirurgie majeure de l'épaule, y compris l'administration d'analgésiques opiacés (dérivés de l'opium) et non opiacés, ou l'administration de médicaments qui produisent un engourdissement et ainsi un soulagement de la douleur dans et autour de l'articulation de l'épaule ou autour des nerfs responsables des membres supérieurs. Nous avons comparé l'utilité d'un bloc nerveux continu du membre supérieur réalisé par injection d'un anesthésique local dans le cou à proximité de la racine des nerfs (bloc interscalénique du plexus brachial - groupe BISPB) avec l'administration d'analgésiques opiacés dans une veine, dans un muscle ou sous la peau (par n'importe quelle voie autre que la bouche) - groupe des opiacés parentéraux.

Les preuves obtenues sont à jour en décembre 2012. Nous avons inclus deux études portant sur 147 participants. Dix-sept participants ont été exclus (16 du groupe BISPB et un de l'autre groupe), ce qui laissait 130 participants : 66 dans le groupe BISPB et 64 dans le groupe des opiacés parentéraux. Les études étaient de qualité faible à modérée en raison de problèmes liés à leur conception, et l'un des essais a été parrainé par un laboratoire pharmaceutique.

L'intensité de la douleur a été évaluée par le patient à l'aide d'une échelle numérique, sur laquelle zéro correspondait à l'absence de douleur et 10 ou 100 à la pire douleur imaginable, pendant 72 heures dans une étude et 48 heures dans l'autre. L'intensité de la douleur postopératoire était significativement moindre dans le groupe BISPB à tous les points-temps dans une étude et à tous les points-temps sauf un dans l'autre étude.

Aucune conclusion concrète ne peut être formulée en raison du petit nombre d'études, qui n'étaient pas de qualité élevée. Toutefois, d'après les preuves disponibles, il peut être observé que dans un des essais, le recours à une analgésie supplémentaire (piritramide) était significativement plus élevé dans le groupe des opiacés parentéraux, tandis que l'autre essai ne mentionnait pas cette donnée. L'incidence des nausées et vomissements était significativement inférieure dans le groupe BISPB en comparaison avec le groupe des opiacés parentéraux. Les complications liées au BISPB ont été pratiquement éliminées lorsque l'échographie a été utilisée dans la réalisation du bloc interscalénique.

Notes de traduction

Traduit par: French Cochrane Centre 15th June, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

Background

Description of the condition

The sensation of pain is one of the vital functions of the human body's nervous system that enables protection of an injured area while healing and repair occur. All surgical procedures are followed by pain, which may trigger or amplify endocrine and metabolic responses, autonomic reflexes, nausea, ileus and muscle spasm to increase postoperative morbidity and mortality (Desborough 2000). The current armamentarium of analgesic drugs and techniques for the management of postoperative pain continues to grow at a rapid rate. However, effective treatment of acute postsurgical pain still poses unique challenges for practitioners (White 2005). Major shoulder surgery is often associated with severe postoperative pain, greater than after gastrectomy or thoracotomy, especially within the first 48 hours. One of the characteristics of this pain is its dynamic component (exacerbation on movement); therefore moderate pain at rest can become severe during rehabilitation. Optimal postoperative pain treatment is, therefore, helpful in enabling early mobilization and rehabilitation, enhancing recovery and reducing morbidity (Borgeat 2007).

Description of the intervention

Different options are available for the management of postoperative pain after major shoulder surgery. These include enteral or parenteral administration of opioid and non-opioid (including non-steroidal anti-inflammatory drugs) analgesics, infiltration of local anaesthetics into the joint (intra-articular) or around the joint (bursal or sub-bursal) and use of regional analgesia (Borgeat 2007), including interscalene brachial plexus block (ISBPB), through different techniques. Patient-controlled analgesia (PCA) is a technique that allows patients to have autonomy in controlling their pain by timing the administration of small doses of an analgesic or local anaesthetic drug. PCA can be used with both parenteral and regional analgesic techniques (Macintyre 2001).

How the intervention might work

Traditionally, parenteral analgesia, which is used for postoperative pain relief, includes intravenous, transdermal, subcutaneous and intramuscular routes for administration of opioids and non-opioids, depending on the type of surgery. Opioid analgesics are commonly associated with opioid-related adverse effects such as nausea and vomiting, pruritus, sleep disturbance and constipation. Interscalene block provides effective anaesthesia and analgesia for shoulder surgery (Fredrickson 2010a).

Winnie was the first to describe the single-injection technique of interscalene brachial plexus block (Winnie 1970). ISBPB, alone or in combination with general anaesthesia, is a very suitable technique for shoulder surgery. The catheter technique for ISBPB, which was first described by Touminen in 1987 (Tuominen 1987), offers many advantages over single-injection ISBPB. These include early and aggressive mobilization, extension of analgesia for prolonged periods and use of smaller doses of local anaesthetics to prevent motor block and reduce opioid requirements and associated side effects (Bishop 2005; Fredrickson 2010a; Russon 2006).

However, ISBPB is an invasive procedure that may lead to serious complications. In addition to commonly associated risks, such as failure, nerve injury, vascular injury, bleeding, phrenic nerve block and Horner's syndrome, interscalene block is associated with risks of pleural puncture, central neuraxial needle placement, cervical spinal cord damage and permanent paralysis (Benumof 2000). The introduction of ultrasound to locate the brachial plexus has helped to reduce these adverse events.

Why it is important to do this review

This review will attempt to distinguish between the effectiveness of continuous ISBPB and that of parenteral opioid in providing better analgesia with minimal adverse effects in patients undergoing major shoulder surgery. This will help anaesthetists, as well as patients, to choose from the two techniques to obtain better pain control with fewer side effects after major shoulder surgery.

Objectives

The objective of this review was to compare the analgesic efficacy of continuous interscalene brachial plexus block (ISBPB) with parenteral opioid analgesia for pain relief after major shoulder surgery.

Methods

Criteria for considering studies for this review

Types of studies

We included randomized controlled trials (RCTs) that compared continuous ISBPB with any form of parenteral opioid analgesia after major shoulder surgery.

Types of participants

We included adult patients (aged over 18 years) undergoing elective major shoulder surgery (shoulder arthroplasty or total shoulder replacement, open rotator cuff repair and internal fixation of shoulder fractures) who received either continuous ISBPB or any form of parenteral opioid analgesia for postoperative pain relief.

We excluded patients undergoing arthroscopic procedures, those who had undergone previous shoulder surgery and those coming in for daycare surgery.

Types of interventions

We included any RCT that compared continuous ISBPB with any form of parenteral opioid analgesia after major shoulder surgery with a minimum duration of follow-up of 12 hours postoperatively (Table 1).

Table 1. Table of comparison
Continuous ISBPB groupParenteral opioid analgesia group
Continuous infusion of any local anaesthetic, in any concentration with or without any other drug, in ISBPB achieved by any techniqueAny opioid drug in any dose given via the intravenous (IV), intramuscular (IM) or subcutaneous (SC) route, whether given as boluses or as continuous infusion

We included studies with:

  1. any method of localization of the brachial plexus by an interscalene approach.

  2. any local anaesthetic, in any concentration with or without any other drug(s), given by the ISBPB technique.

  3. any form(s) of parenteral (intravenous, intramuscular, subcutaneous) opioid analgesia technique.

  4. any parenteral opioid analgesic drug(s), given in any dosage.

Types of outcome measures

Primary outcomes
  1. The effectiveness of pain relief after major shoulder surgery using continuous ISBPB or parenteral opioid analgesia for the entire follow-up period (minimum 12 hours).

  2. Complications related to ISBPB including those related to technique (failure, pneumothorax, nerve injury, Horner's syndrome, vascular injury, haematoma, bleeding, catheter dislocation, infection, facial nerve palsy) and those related to drugs (nausea, vomiting, pruritus, metallic taste, motor block, sedation, respiratory depression, central nervous system excitation).

  3. Complications related to parenteral analgesia (nausea, vomiting, pruritus, sedation, respiratory depression).

Secondary outcomes
  1. Effectiveness of pain relief at mobilization.

  2. Supplemental analgesia, if used.

  3. Time to mobilization.

  4. Participant satisfaction.

  5. Length of stay in postanaesthesia care unit (PACU).

  6. Length of stay in hospital.

Search methods for identification of studies

Electronic searches

We searched the following databases.

  1. The Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12) (Appendix 1).

  2. MEDLINE (via PubMed) (1950 to December 2012) (Appendix 2).

  3. EMBASE (1980 to December 2012) (Appendix 3).

  4. ISI Web of Science (1954 to December 2012) (Appendix 4).

  5. CINAHL (EBSCO host) (1982 to December 2012) (Appendix 5).

We imposed no language restrictions.

Searching other resources

We included all relevant studies irrespective of the language of publication. We manually checked the reference lists of relevant studies to identify trials missed by the electronic search strategy.

We contacted primary authors of identified trials to ask for more information, if required.

We searched for ongoing trials on the following websites.

  1. http://www.controlled-trials.com.

  2. http://www.clinicaltrials.gov.

Data collection and analysis

Selection of studies

We (HU and KS) independently reviewed the titles and abstracts identified by the searches. We obtained full copies of potentially relevant trials and assessed all full copies according to the parameters outlined in Criteria for considering studies for this review. We assessed only trials meeting these criteria for methodological quality. No disagreement arose during this process; therefore we did not consult the third review author (FK).

Data extraction and management

Two review authors (HU and KS) independently extracted data using a data extraction form (Appendix 6) modified from one developed by the Cochrane Anaesthesia Review Group (CARG). We resolved discrepancies by discussion. We extracted data (as far as was possible) on the basis of an intention-to-treat (ITT) analysis. We contacted primary investigators to ask for missing data. Two review authors (HU and KS) independently entered all data into Review Manager (RevMan 5.1).

Assessment of risk of bias in included studies

We assessed trial quality using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We observed whether inclusion and exclusion criteria were clearly defined in the text. Criteria included the following.

  1. Random sequence generation.

  2. Allocation concealment.

  3. Blinding of participants, personnel and outcome assessors.

  4. Incomplete outcome data.

  5. Selective reporting.

Based on the above, we rated study validity as follows.

  1. Low risk of bias: if most of the above criteria are met.

  2. High risk of bias: if most of the above criteria are not met.

  3. Unclear risk of bias: if criteria are expressed in an unclear manner.

We (HU and KS) resolved any disagreements regarding the assessment by discussion and by coming to consensus.

Measures of treatment effect

We planned to express the treatment effect as a pooled risk ratio and 95% confidence interval (CI) for dichotomous data, and as a mean difference and 95% CI for continuous data. We planned to use a fixed-effect model when minimal heterogeneity existed; otherwise a random-effects model was planned. In cases in which such data combination was not possible or was inappropriate (in the presence of significant clinical heterogeneity or for other reasons), we provided a narrative synthesis.

Unit of analysis issues

In the studies included in the review, participants were randomly assigned to either group (ISBPB or parenteral opioid), and a measurement for each outcome from each participant was recorded and analysed. In cases of multiple observations for the same outcome, we computed the effect measure for each individual participant that incorporated all time points.

Dealing with missing data

Intention-to-treat analysis is recommended to minimize bias. No consensus has been reached on how to handle missing data in ITT analysis in systematic reviews (Higgins 2011). We excluded all participants for whom outcome data were missing.

Assessment of heterogeneity

We planned statistical heterogeneity using the Chi2 test (significant at P < 0.1) before considering the appropriateness of pooling the data and proceeding with a meta-analysis.

Assessment of reporting biases

We looked at the number of outcomes presented in the methods section of the included studies and confirmed this number in the results section of the trial. We planned to provide a funnel plot to detect publication bias or a difference between smaller and larger studies expressed by asymmetry (Egger 1997). However, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions, Chapter 10 (Higgins 2011), at least 10 studies are needed to create a funnel plot.

Data synthesis

We planned to enter the data extracted from the studies into Review Manager 5.1.

We also planned to:

  1. pool the data from various trials, when appropriate, and perform analysis in both groups;

  2. record either the means of an event or the number of participants experiencing an event in each group;

  3. express the treatment effect as a pooled risk ratio and 95% CI for dichotomous data, and as a mean difference and 95% CI for continuous data;

  4. use a fixed-effect model when minimal heterogeneity existed, otherwise a random-effects model; and

  5. generate forest plots when only a single study was available for a particular outcome. In situations in which variables were presented differently, we planned to equate each variable by methods prescribed by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Subgroup analysis and investigation of heterogeneity

If appropriate data were found, we planned subgroup analysis based on:

  1. the type of local anaesthetic used;

  2. the type of analgesic drug used;

  3. a combination of drugs in either technique;

  4. any technique for localization of brachial plexus; and

  5. the type of surgery performed (in cases of multiple surgical procedures, we will subanalyse each procedure).

Heterogeneity was assessed as mentioned in the section Assessment of heterogeneity.

Sensitivity analysis

We planned a sensitivity analysis if methodological quality or characteristics of participants in the studies differed significantly and adequate data were available.

Results

Description of studies

Results of the search

We identified 122 abstracts from the 2774 results obtained by searching according to the methods mentioned in Search methods for identification of studies. The details are presented in Figure 1. Of these, 47 abstracts qualified for full-paper analysis after mutual discussion. We accessed all 47 full-text papers, and 45 were excluded because of inappropriate participants or comparison groups. Thus two studies (Hofmann-Kiefer 2008; Wei 2012) qualified to be included in the final analysis, of which one study was written in Chinese and required translation for extraction of data.

Figure 1.

Abstracts search flow diagram.

Included studies

We included two studies in the review. The sample size was 147 participants (87 in Hofmann-Kiefer 2008 and 60 in Wei 2012). See Characteristics of included studies for details. Because of the small number of studies included in the review and significant clinical heterogeneity among them, we were unable to perform meta-analysis in this review.

Excluded studies

Upon the advice of Dr Mathew Zacharia and Professor Nathan Pace, we have listed in the Excluded studies section all studies that we retrieved as full-text papers from literature searches that did not meet the eligibility criteria for inclusion in the review. Forty-five studies have been excluded, and the reasons for their exclusion are mentioned in the Characteristics of excluded studies. These studies did not include appropriate interventions or appropriate participants, as mentioned in the Criteria for considering studies for this review.

Risk of bias in included studies

The overall quality of each study was evaluated according to the methodology mentioned in Assessment of risk of bias in included studies. The different bias domains are presented in Characteristics of included studies. A graph and a summary of the risk of bias of included studies are presented in Figure 2 and Figure 3.

Figure 2.

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

Figure 3.

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

Effects of interventions

Hofmann-Kiefer 2008 enrolled 87 participants. In all, 17 participants were excluded for reasons mentioned in Characteristics of included studies, and they were removed from the analysis. A total of 16 participants received continuous ISBPB as postoperative analgesia, and one was given parenteral opioids. The authors of the study used a nerve stimulator to locate the brachial plexus.

Wei 2012 enrolled 60 participants, all of whom completed the study. Four participants were excluded according to exclusion criteria. Investigators used ultrasound technique to perform brachial plexus block.

Outcomes

Primary outcomes
Effectiveness of pain relief

The effectiveness of pain relief was assessed by visual analogue scale (VAS) (Hofmann-Kiefer 2008) and numerical rating pain scale (NRPS) (Wei 2012). Study authors reported observations at different time points (Hofmann-Kiefer 2008 reported at four time points and Wei 2012 at three time points). Because only two studies qualified for inclusion in the review and because significant clinical heterogeneity was present among the studies, we did not perform the meta-analysis; hence, the results are reported in a narrative form.

One hundred thirty participants received continuous ISBPB (66) or parenteral opioid analgesia (64). Hofmann-Kiefer 2008 followed participants for 72 hours postoperatively, whereas Wei 2012 followed participants for 48 hours postoperatively.

Hofmann-Kiefer 2008 reported pain scores at six, 24, 48 and 72 hours after surgery, and pain scores were significantly lower at six, 24 and 72 hours in the ISBPB group than in the group given parenteral opioids. However, pain scores were similar at 48 hours among the two groups. In the Wei 2012 study, pain scores were reported at arrival to the PACU and 24 and 48 hours after surgery; scores were significantly lower in the ISBPB group at all time points.

Adverse effects

Incomplete block did not occur in any participant; therefore, no participants were excluded before surgery. Postoperatively, 17 participants were withdrawn (Hofmann-Kiefer 2008) because of one or another adverse event (see Risk of bias in included studies) and were not included in the analysis. Of these, 16 were from the ISBPB group (one for no C5 block, nine for catheter dislocations, one for Horner's syndrome, four for diaphragmatic paresis leading to dyspnoea and one on the participant's choice) and one from the parenteral opioid group (pruritus). Four participants were excluded from the Wei 2012 study, according to exclusion criteria.

Secondary outcomes

Of the secondary outcomes listed in the Types of outcome measures, only the following have been found to be reported in the included studies. The remaining are not reported at all or are mentioned only in narrative rather than numerical form.

Hofmann-Kiefer 2008 mentions that VAS scores were lower in the ISBPB group during physiotherapy at day two (P = 0.016) but were similar at day three. Investigators used piritramide boluses (3.75 to 7.5 mg intravenously) when the pain score exceeded 40 on a scale of 100. Six of 36 participants (16.6%) in the ISBPB group and 11 of 34 (32.3%) in the parenteral opioid group required boluses of piritramide; this was statistically significant (P < 0.01). Regarding nausea and/or vomiting, two of 36 (5.5%) participants in the continuous ISBPB group versus nine of 34 (26.4%) in the parenteral opioid group developed nausea and/or vomiting during the study; this again was statistically significant. No catheter infections were reported.

Wei 2012 looked at participant satisfaction, which was significantly greater (P < 0.01) in the ISBPB group. This study also reported nausea and/or vomiting as an adverse event that was significantly more frequent in the parenteral opioid group (one of 30 (3.3%) in the ISBPB group vs eight of 30 (26.6%) in the parenteral opioid group). The drug used for postoperative analgesia was sufentanil.

Discussion

Summary of main results

The primary focus of this review was to look at clinically and statistically significant differences in postoperative pain management following major shoulder surgery when continuous ISBPB is compared with parenteral opioids. We also looked at adverse effects related to both techniques, use of supplemental analgesia, participant satisfaction and length of hospital stay.

We included two randomized controlled trials (Hofmann-Kiefer 2008; Wei 2012) consisting of 147 participants, of whom 17 were excluded from analysis—all from the Hofmann-Kiefer 2008 study. Of these 17, 16 had complications related to continuous ISBPB (one no C5 block, nine catheter dislocation, one Horner's syndrome, four diaphragmatic paresis leading to dyspnoea and one poor choice by the participant) and one had complications related to parenteral opioid analgesia (pruritus). Therefore 130 participants were included in the analysis (66 in the continuous ISBPB group and 64 in the parenteral opioid group). The included studies carried a high risk of bias, mainly for the reasons of absence of allocation concealment, lack of blinding and large numbers of dropouts. Both mentioned primary outcomes and several secondary outcomes. A nerve stimulator was used to locate the brachial plexus in all participants in the Hofmann-Kiefer 2008 study, and Wei 2012 used ultrasound to perform brachial plexus block, which may be the reason why no complications related to ISBPB were reported in this study. Because of the small number of studies included in the review, high risk of bias and significant clinical heterogeneity, no concrete conclusions can be drawn. However, following is the summary reported by these two studies.

Effectiveness of pain relief was assessed at different time points for up to 72 hours by Hofmann-Kiefer 2008, and up to 48 hours by Wei 2012. Hofmann-Kiefer 2008 used VAS and Wei 2012 used NRPS to evaluate postoperative pain. Pain scores were significantly lower in the ISBPB group at six, 24 and 72 hours, whereas they were similar at 48 hours in the Hofmann-Kiefer 2008 study. Pain scores were significantly lower in the ISBPB group, as reported by Wei 2012, at all time points (upon arrival to PACU and 24 and 48 hours postoperatively).

Supplemental analgesia was used in the Hofmann-Kiefer 2008 study; the drug used was piritramide, whereas Wei 2012 used sufentanil as supplemental analgesia. The number of boluses was significantly greater in the parenteral opioid group. Adverse effects mentioned included nausea and vomiting, which was significantly more frequent in the parenteral opioid group, as reported by both studies (Hofmann-Kiefer 2008; Wei 2012).

Overall completeness and applicability of evidence

Both studies included in this review had participants, interventions and outcomes that were appropriate to our objectives and outcomes, both primary and secondary. The main issues with the applicability of this evidence include the small number of studies, the high risk of bias in these studies and the presence of significant clinical heterogeneity. Another important point is the method used to perform brachial plexus block. It is evident that ISBPB-related complications were significantly more frequent when a nerve stimulator was used when compared with ultrasound technique. Another aspect worth mentioning is the usual current practice of using ultrasound for performing brachial plexus block; one study in this review did not use ultrasound and may not represent usual current practice.

Quality of the evidence

Generally, the quality of evidence included in our review was limited by a high risk of bias of the included studies, as evaluated from the information provided by the papers. The included studies were prospective randomized clinical trials in which randomization was done by computer or by random number tables. These studies were not placebo-controlled, and sham catheters were not used for ethical reasons, thus making the studies unblinded. These studies were heterogeneous clinically, as different methods were used to perform ISBPB. We were unable to retrieve the protocol and thus were unable to compare published outcomes versus proposed ones.

Potential biases in the review process

We strictly followed the protocol to perform the review and could think of no source of potential bias in the review process.

Agreements and disagreements with other studies or reviews

We found only one review article, which is actually a critical appraisal of current techniques (Fredrickson 2010a), that reviewed the postoperative analgesic techniques used for shoulder surgery. The results of this review are similar to those reported in our review. This review also does not include a meta-analysis.

Authors' conclusions

Implications for practice

Based on the evidence generated by this review, no reasonable conclusions can be drawn. Because of the presence of significant clinical heterogeneity among the two included studies, meta-analysis could not be performed. Current practice is to perform single-shot ISBPB as well as placement of ISBPB catheters by using ultrasound assistance; for this reason, the study by Hofmann-Kiefer 2008 is unlikely to be performed again.

Implications for research

Further randomized controlled trials with low risk of bias are needed to generate good-quality evidence on the topic. Future research should focus on blinding studies to make them stronger and using ultrasound to perform ISBPB.

Acknowledgements

We would like to thank Mathew Zacharias (content editor); Cathal Walsh (statistical editor); Nathan Pace (co-ordinating editor), Jean Pierre Estebe, Jeff Swenson and Thomas Fichtner Bendtsen (peer reviewers) and Janet Wale (consumer editor) for help and editorial advice provided during the preparation of this systematic review. We would also like to thank Karen Havhannisyan (trials search Co-ordinator, CARG) for developing the search strategies and running them and for helping us to acquire the full text of several papers, and Jane Cracknell (managing editor, CARG) for co-ordinating this review.

We are grateful to Dr Xiaoli Ge for extracting data from the Chinese study (Wei 2012).

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. CENTRAL search strategy

Search terms

#1           (shoulder or rotator cuff):ti,ab

#2           MeSH descriptor Shoulder, this term only

#3           MeSH descriptor Shoulder Joint explode all trees

#4           MeSH descriptor Rotator Cuff explode all trees

#5           MeSH descriptor Arthroplasty, this term only

#6           MeSH descriptor Arthroplasty, Replacement explode all trees

#7           (#1 OR #2 OR #3 OR #4 OR #5 OR #6)

#8           MeSH descriptor Analgesia, Patient-Controlled explode all trees

#9           MeSH descriptor Anesthetics, Intravenous, this term only

#10         MeSH descriptor Anesthesia, Intravenous, this term only

#11         MeSH descriptor Nerve Block explode all trees

#12         (intravenous or intramuscular or transdermal or subcutaneous):ti,ab

#13         (ISBPB or ISNB or (interscalene near (block or an?esth* or analg* or continuous)))

#14         (#8 OR #9 OR #10 OR #11 OR #12 OR #13)

#15         (#7 AND #14)

Appendix 2. MEDLINE (via PubMed) search strategy

Search terms
#1 shoulder in TI, AB
#2 shoulder near (surg* or replac* or arthroplasty)
#3 rotator cuff in TI, AB
#4 explode Shoulder / all subheadings
#5 explode Shoulder Joint/ all subheadings
#6 explode Rotator Cuff/ all subheadings
#7 "Arthroplasty-" / all SUBHEADINGS in MIME,MJME,PT
#8 "Arthroplasty-Replacement" / all SUBHEADINGS in MIME,MJME,PT
#9 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8
#10 interscalene near block
#11 Patient control* near analgesia
#12 interscalene near (block or an?esth* or analg* or continuous or (brachial plexus)
#13 explode "Analgesia-Patient-Controlled" / all SUBHEADINGS in MIME,MJME,PT
#14 (explode "Anesthetics-Intravenous" / all SUBHEADINGS in MIME,MJME,PT) or (explode "Anesthesia-Intravenous" / all SUBHEADINGS in MIME,MJME,PT)
#15 interscalene
#16 explode Injections-Intramuscular/ all subheadings
#17 explode Administration-Cutaneous/ all subheadings
#18 explode Injections-Subcutaneous/ all subheadings
#19 explode Infusions-Intravenous/ all subheadings
#20 parenteral near (an?esth* or analg*)
#21 ISBPB or ISNB
#22 explode nerve block/ all subheadings
#23 (parenteral or intravenous or intramuscular or transdermal or subcutaneous) in TI, AB
#24 #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23
#25 #9 and #24

Appendix 3. EMBASE search strategy

Search terms

1     shoulder/ or exp rotator cuff/ or exp shoulder arthroplasty/ or arthroplasty/ or (shoulder or rotator cuff).ti,ab. (32445)

2     exp patient controlled analgesia/ or intravenous anesthetic agent/ or intravenous anesthesia/ or exp nerve block/ or postoperative pain/ or brachial plexus anesthesia/ or local anesthetic agent/ or (intravenous or intramuscular or transdermal or subcutaneous).ti,ab. or (ISBPB or ISNB or (interscalene adj3 (block or an?esth* or analg* or continuous))).mp. (274975)

3     1 and 2 (1699)

4     (randomized-controlled-trial/ or randomisation/ 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. (3269130)

5     4 and 3 (659)

6     from 5 keep 1-659 (659)

Appendix 4. ISI Web of Science search strategy

Search terms

1     shoulder/ or exp rotator cuff/ or exp shoulder arthroplasty/ or arthroplasty/ or (shoulder or rotator cuff).ti,ab. (32445)

2     exp patient controlled analgesia/ or intravenous anesthetic agent/ or intravenous anesthesia/ or exp nerve block/ or postoperative pain/ or brachial plexus anesthesia/ or local anesthetic agent/ or (intravenous or intramuscular or transdermal or subcutaneous).ti,ab. or (ISBPB or ISNB or (interscalene adj3 (block or an?esth* or analg* or continuous))).mp. (274975)

3     1 and 2 (1699)

4     (randomized-controlled-trial/ or randomisation/ 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. (3269130)

5     4 and 3 (659)

6     from 5 keep 1-659 (659)

Appendix 5. CINAHL (EBSCO host) search strategy

Search terms

S1           TX ( shoulder or rotator cuff ) and AB ( shoulder or rotator cuff )

S2           (MH "Shoulder")

S3           (MH "Shoulder Joint+")

S4           (MH "Rotator Cuff+")

S5           (MH "Arthroplasty") or (MH "Arthroplasty, Replacement+")

S6           S1 or S2 or S3 or S4 or S5

S7           (MH "Patient-Controlled Analgesia")

S8           (MH "Anesthetics, Intravenous") or (MH "Anesthesia, Intravenous")

S9           (MM "Nerve Block")

S10         AB intravenous or intramuscular or transdermal or subcutaneous

S11         TX ISBPB or ISNB

S12         TX interscalene and TX ( block or an?esth* or analg* or continuous )

S13         S7 or S8 or S9 or S10 or S11 or S12

S14         S6 and S13

S15         TX ( random* or placebo* or clinical trial* ) or TX ( (single or double or triple) and (blind* or mask*) )

S16         TX animal* not TX ( (animal* and human*) )

S17         S15 not S16

S18         S14 and S17

Appendix 6. Data extraction form

Continuous interscalene blockade versus parenteral analgesia for postoperative pain relief after major shoulder surgery

Study ID:
Authors:
MEDLINE journal ID:
Year of publication:
Language:
  RCT CCT Observational
Type of study:      

 

Comments on study design:

Quality of concealment of random allocation

Allocation was not concealed                                                                        

(e.g. quasi-randomization)                                                           

 

Allocation concealment was inadequate                                                    

                                                                                                 

 

Methods of concealment were unclear or were not stated                                                          

                                                                                                 

 

Concealment was adequate                                                                             

(e.g. numbered, sealed opaque envelopes; central assignment by co-ordinating centre)

 

 

Inclusion and exclusion criteria were not clearly defined in the text                

 

 

 

Outcomes of participants who withdrew or were excluded after allocation were NEITHER detailed separately NOR included in an intention-to-treat analysis            

Outcomes of participants who withdrew or were excluded after allocation were EITHER detailed separately OR included in an intention-to-treat analysis     

OR the text stated there were no withdrawals    

 

 

Treatment and control groups were NOT adequately described at entry          

Treatment and control groups were adequately described at entry

A minimum of four admission details were described                                          

 

Methods

 Low risk of biasHigh risk of biasUnclear
Subject-blinded   
Physician type one-blinded             
Physician type two-blinded   
Outcome assessor-blinded   

Participants 

Number of eligible participants Number enrolled in study 
Number of males Number of females 

 

Intervention

 

Drugs (specify)                         DoseDurationRoute
Interscalene group    
Parenteral group    

 

Comment on treatment

 

 

 Interscalene group
n

Parenteral group

n

Withdrawals  
Lost to follow-up  

 

Primary outcome Effectiveness of pain relief
# (%)                    
Total participants
n
Interscalene group  
Parenteral group  

 

Secondary outcome

complications

Interscalene groupParenteral group
n (%)

 

n

(%)
Block failure    
Pneumothorax    
Nerve injury    
Horner’s syndrome    
Vascular injury    
Haematoma    
Bleeding    
Catheter dislocation    
Infection    
Metal taste    
Motor block    
Cardiovascular depression    
Central nervous system excitation    
Nausea and vomiting    
Pruritus    
Sedation    
Respiratory depression    
Others    

 

Secondary outcomeInterscalene groupParenteral group
n (%)

 

n

(%)
Duration of analgesia (hours)    
LOS PACU (hours)    
Continuous outcomes:
LOS hospital (days)
    
Participant satisfaction    
Supplemental analgesia    

 

Changes in protocol:

 

Contact with author:

 

Other comments on the study: 

 

 

 

Contributions of authors

Conceiving of the review: Hameed Ullah (HU).
Co-ordinating the review: HU.
Undertaking manual searches: HU, Khalid Samad (KS).
Screening search results: HU, KS.
Organizing retrieval of papers: HU, KS.
Screening retrieved papers against inclusion criteria: HU, KS.
Appraising quality of papers: HU, KS.
Abstracting data from papers: HU.
Writing to authors of papers to ask for additional information: KS.
Providing additional data about papers: HU, KS.
Obtaining and screening data on unpublished studies: HU, KS.
Managing data for the review: HU, KS.
Entering data into Review Manager (RevMan 5.1): HU.
Handling RevMan statistical data: HU, KS.
Performing other statistical analyses not using RevMan: HU, KS.
Entering data double: data entered by person one, HU; data entered by person two, KS.
Interpreting data: HU, KS, Fauzia A Khan (FK).
Making statistical inferences: HU, KS, FK.
Writing the review: HU.
Securing funding for the review: not applicable.
Performing previous work that was the foundation of the present study: HU.
Servind as guarantor for the review (one author): HU.
Taking responsibility for reading and checking the review before submission: KS, FK,

Declarations of interest

Hameed Ullah: none known.

Khalid Samad: none known.

Fauzia A Khan: none known.

Sources of support

Internal sources

  • Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.

External sources

  • No sources of support supplied

Differences between protocol and review

  1. The title has undergone a minor change. "Continuous interscalene blockade" has been changed from the protocol (Ullah 2008) to "Continuous interscalene brachial plexus block" in the review.

  2. In the review, we searched CENTRAL, MEDLINE, EMBASE, CINAHL and ISI Web of Science, whereas we mentioned only the first three databases in the protocol.

  3. The risk of bias tool has been updated and the methods amended to reflect this.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Hofmann-Kiefer 2008

MethodsProspective, randomized, clinical trial
Participants87, ASA one to three, adult patients undergoing open rotator cuff repair or acromioplasty
Interventions

Group one: ISBPB with 40 mL of 0.75% ropivacaine, followed by patient-controlled continuous ISBPB using 0.2% ropivacaine infusion at the rate of 10 mg/h plus a bolus of 8 mg with a lockout of 20 minutes up to a maximum of 450 mg in 24 hours

Group two: Patient-controlled opioid analgesia with piritramide bolus of 2 mg and a lockout of 10 minutes with no background infusion. Maximum: four-hour dose: 30 mg

Duration of study observations was 72 hours; however, the infusion of analgesic solutions was continued for up to about 80 hours postoperatively

Outcomes

Pain intensity

Consumption of opioids

Nausea and vomiting

Notes

Protocol violation occurred three times in each group during the study period

This study was supported by AstraZeneca International

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomization table
Allocation concealment (selection bias)High riskNo mention in the methodology
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnblinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskPain was evaluated by an unblinded investigator
Incomplete outcome data (attrition bias)
All outcomes
High risk17 participants were excluded for various reasons. Of these, 16 were from group one (one for no C5 block, nine for catheter dislocations, one for Horner's syndrome, four for diaphragmatic paresis leading to dyspnoea and one on participant's choice) and one from Group two (pruritus). Thus, 70 participants completed the study and remained in the final analysis
Selective reporting (reporting bias)Low riskAll outcomes mentioned are reported

Wei 2012

MethodsProspective, randomized clinical trial
Participants60 patients undergoing rotator cuff surgery
Interventions

Group ISB + GA—30 participants received preoperative ISBPB (ultrasound guided) with 20 mL of 0.5% ropivacaine along with general anaesthesia. This was followed postoperatively by continuous ISBPB with a PCA device programmed to deliver 0.2% ropivacaine infusion at 4 mL per hour and a bolus of 5 mL on demand with a lock-out interval of one hour

Group GA—30 participants received general anaesthesia, followed postoperatively by patient-controlled intravenous analgesia with a PCA device programmed to deliver 1 µg/mL sufentanil infusion at 2 mL per hour and a bolus of 1 mL on demand with a lock-out interval of 15 minutes

Duration of study observations was 48 hours. The duration of injection of analgesic infusions was not mentioned

Outcomes

Haemodynamic variables

Numerical pain rating scores

Participant satisfaction

NotesArticle in Chinese. Data extracted with the help of Dr Xiaoli Ge. Inclusion and exclusion criteria are not clearly mentioned. Four participants were excluded according to exclusion criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)High riskNo concealment
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnblinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnclear
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollowing eligibility, four participants were excluded based on exclusion criteria: One could not understand the PCA device, one refused ISB, two were using long-term analgesic drugs
Selective reporting (reporting bias)Low riskAll outcomes mentioned are reported

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Al-Kaisy 1998Not appropriate participants (arthroscopic surgery). Not appropriate intervention. Single-shot ISBPB
Bain 2001Not appropriate intervention. Single-shot ISBPB. Both groups received postoperative pethidine PCA
Barber 2002Not appropriate intervention. None of the groups underwent ISBPB
Beaudet 2008Not appropriate intervention. ISBPB compared with intra-articular analgesia with no parenteral opioid group
Birnbaum 2007Not appropriate intervention. All three groups had ISBPB with no parenteral opioid group
Blumenthal 2005Not appropriate intervention. Both groups received morphine PCA
Borgeat 1997Not appropriate intervention. Both groups had ISBPB
Borgeat 1998Not appropriate intervention. Both groups had ISBPB
Borgeat 2000Not appropriate intervention. Both groups had ISBPB
Ciccone 2008Not appropriate intervention. All participants had single-shot ISBPB. No continuous parenteral opioid group for postoperative analgesia
Contreras-Domínguez 2008Not appropriate intervention. Single-shot ISBPB or intra-articular block followed by continuous ISBPB or intermittent morphine
Culebras 2001Not appropriate intervention. Single-shot ISBPB in all three groups
Delaunay 2005Not appropriate intervention. Single-shot ISBPB in all participants with continuous ISBPB compared with continuous subacromial analgesia
Dewees 2006Not appropriate intervention. Single-shot ISBPB
Esteves 2002Not appropriate intervention. Single-shot ISBPB in both groups
Fontana 2009Not appropriate intervention. Single-shot ISBPB, no continuous parenteral opioid given postoperatively. Not appropriate participants, participants undergoing arthroscopy
Fredrickson 2010Not appropriate participants. Minor arthroscopic shoulder surgery was included
Fredrickson 2011Not appropriate intervention. No parenteral opioid group
Goebel 2010Not appropriate intervention. Both groups had ISBPB with no postoperative continuous infusion in either group
Gohl 2001Not appropriate intervention. Single-shot ISBPB. No parenteral opioid group
Gonano 2009Not appropriate intervention. Single-shot ISBPB
Grossi 1998Not appropriate intervention. Single-shot ISBPB
Hadzic 2005Not appropriate intervention. Single-shot ISBPB
Ilfeld 2003Not appropriate intervention. Both groups had single-shot ISBPB followed by continuous ISBPB compared with oral opioids
Ilfeld 2006Not appropriate intervention. Continuous ISBPB in both groups until 0600 hours of postoperative day one. No continuous parenteral opioid group in the study
Iskandar 2003Not appropriate intervention. Both groups received continuous ISBPB. No continuous parenteral opioid group
Kean 2006Not appropriate intervention. Both groups had ISBPB
Kinnard 1994Not appropriate intervention. Single-shot ISBPB
Klein 2000Not appropriate intervention. Both groups had ISBPB. No continuous parenteral opioid group
Klein 2001Not appropriate intervention. Continuous ISBPB compared with continuous intra-articular infusion. No continuous parenteral opioid group
Klein 2003Not appropriate intervention. Single-shot ISBPB followed by continuous ISBPB or intra-articular infusion. No parenteral opioid group
Laurila 2002Not appropriate participants (arthroscopic surgery). Not appropriate intervention. Single-shot ISBPB
Le 2008Not appropriate intervention. Both groups had continuous ISBPB with different concentrations of local anaesthetic. No parenteral opioid group
Lehtipalo 1999Not appropriate participants. Participants were not of major shoulder surgery
Mahmoodpoor 2011Not appropriate intervention. Single-shot ISBPB
Mariano 2009Not appropriate intervention. Single-shot ISBPB followed by continuous ISBPB compared with oral opioids. No parenteral opioid group
Muittari 1998Not appropriate intervention. Single-shot intrabursal or ISBPB with all participants receiving postoperative fentanyl PCA
Nisar 2008Not appropriate intervention. Single-shot ISBPB
Patacsil 2008Not appropriate intervention. ISBPB compared with intra-articular analgesia
Pennekamp 2004Not appropriate intervention. Single-shot ISBPB
Pere 1993Not appropriate participants. Control group (without ISBPB) included participants with minor shoulder surgery who did not require ISBPB
Sia 2003Not appropriate intervention. All participants received ISBPB with or without epinephrine
Singelyn 1999Not appropriate intervention. All three groups received ISBPB with no parenteral opioid group
Singelyn 2004Not appropriate intervention. Intra-articular, supracapsular ISBPB and a no-block group were compared. Postoperative analgesia consisted of paracetamol and morphine
Tamosiūnas 2004Not appropriate intervention. Both groups had ISBPB. No continuous parenteral opioid group

Ancillary