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Local anaesthetic sympathetic blockade for complex regional pain syndrome

  1. Tasha R Stanton1,2,*,
  2. Benedict M Wand3,
  3. Daniel B Carr4,
  4. Frank Birklein5,
  5. Gunnar L Wasner6,
  6. Neil E O'Connell7

Editorial Group: Cochrane Pain, Palliative and Supportive Care Group

Published Online: 19 AUG 2013

Assessed as up-to-date: 31 JUL 2013

DOI: 10.1002/14651858.CD004598.pub3


How to Cite

Stanton TR, Wand BM, Carr DB, Birklein F, Wasner GL, O'Connell NE. Local anaesthetic sympathetic blockade for complex regional pain syndrome. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD004598. DOI: 10.1002/14651858.CD004598.pub3.

Author Information

  1. 1

    Neuroscience Research Australia, Randwick, Australia

  2. 2

    University of South Australia, The Sansom Institute for Health Research, School of Health Sciences, Adelaide, Australia

  3. 3

    The University of Notre Dame Australia, School of Physiotherapy, Fremantle, W, Australia

  4. 4

    Tufts Medical Center, Department of Anesthesia, Boston, USA

  5. 5

    Johannes Gutenberg University, University Medical Centre, Mainz, Germany

  6. 6

    Christian-Albrechts University of Kiel, Neurological Clinic, Kiel, Schleswig-Holestein, Germany

  7. 7

    Brunel University, Centre for Research in Rehabilitation, School of Health Sciences and Social Care, Uxbridge, Middlesex, UK

*Tasha R Stanton, The Sansom Institute for Health Research, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, South Australia, 5001, Australia. t.stanton@neura.edu.au. tasha.stanton@unisa.edu.au.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 19 AUG 2013

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This is not the most recent version of the article. View current version (28 JUL 2016)

 
Characteristics of included studies [ordered by study ID]
Aydemir 2006

MethodsRCT, parallel design


Participantsn = 25; divided into 3 groups (Group 1: n = 9; Group 2: n = 9; Group 3: n = 7)

Age mean (SD):

Group 1: 21.9 years (1.05)

Group 2: 21.4 years (0.73)

Group 3: 21.1 years (0.38)

Upper limb CRPS Type I (dominant arm: Group 1, n = 6; Group 2, n = 9; Group 3, n = 2); excluded if had SGB block in last month.

Diagnostic criteria: IASP (Bruehl 1999)

Duration of symptoms:

Group 1 (0 - 3 months, n = 5; 3 - 6 months, n = 2; > 6 months, n = 2)

Group 2 (0 - 3 months, n = 6; 3 - 6 months, n = 2; > 6 months, n = 1)

Group 3 (0 - 3 months, n = 5; 3 - 6 months, n = 0; > 6 months, n = 2)

Type of initiating injury:

Group 1 (Trauma, n = 7; Fracture, n = 2; Idiopathic, n = 0)

Group 2 (Trauma, n = 2; Fracture, n = 5; Idiopathic, n = 2)

Group 3 (Trauma, n = 3; Fracture, n = 4; Idiopathic, n = 0)

Concomitant treatments: All groups received 21 sessions of physiotherapy which involved exercises, contrast baths, transcutaneous electrical nerve stimulation (TENS), pneumatic compression. If necessary, all groups had access to medical treatment which involved 500 mg oral paracetamol pill, 3 g/day.

Medicolegal factors: not reported

Previous treatment: not reported


InterventionsGroup 1: Stellate ganglion lidocaine block (real) plus sham stellate ganglion ultrasound block

Group 2: Stellate ganglion ultrasound block (real) plus sham stellate ganglion lidocaine block

Group 3: Sham stellate ganglion lidocaine block and sham stellate ganglion ultrasound block

For the purpose of this review, we included comparisons between Group 1 and Group 3 as placebo-controlled and comparisons of Group 1 and Group 2 as comparison with another active intervention.

SGB lidocaine (real):

Location: C6 level; 1.5 cm lateral to central line, 4 - 5 cm deep

Dosage:10 ml of 1% lidocaine

Number of blocks performed: 10

Eval. of technical adequacy of block: No.

SGB (sham):

Identical site, but injected 10 ml of saline.

Number of blocks not reported.

SGB ultrasound (real):

Probe size of 1 cm²; 5 minutes of intermittent US at 3 watt/cm² over the affected site (over stellate ganglion).

Number of treatments not reported.

SGB ultrasound (sham):

5 minutes, no energy delivered.

Number of treatments not reported.


OutcomesSpontaneous pain:

0 - 10cm visual analogue scale

Outcomes measured pretreatment, post-treatment, and at one-month follow-up.

Adverse events/side effects not reported.


Country of originTurkey


Study aimTo investigate the efficacies of stellate ganglion blockage (SGB) with lidocaine and ultrasound in CRPS


NotesThis study was translated and interpreted by a researcher fluent in Turkish. The study author, TS, worked with the researcher to fully interpret and score.

Conflict of interests not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomized"

Comment: Method of randomisation not reported

Allocation concealment (selection bias)Low riskEnvelope method used to conceal allocation; group assignment generated by an independent person.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "double blind"

Comment: Reported that participants and personnel blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskReported that outcome assessors blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDrop-outs/withdrawals not reported.

Selective reporting (reporting bias)Low riskAll prespecified outcomes were adequately reported on.

Adequate sample size?High riskGroup 1, n = 9; Group 2, n = 9; Group 3, n = 7

Adequate duration of follow up?Unclear riskOne month follow-up

Free of other bias?Low riskPain scores were not significantly different between groups at baseline; identical timing of outcome assessment between groups.

Bonelli 1983

MethodsRCT, parallel design


Participantsn = 19

Age: mean(SD) 52.33 (5.04)

Gender: not reported.

Diagnosis of RSD following peripheral nerve injury.

At least 3 of the following clinical signs: hyperpathia, allodynia, vasomotor disturbance, trophic signs, oedema, limited motion.

Mean (SD) duration of pain:

Stellate ganglion block group: 6.55 (3.94) months

IVRB guanethidine group: 17.55(14.9) months

Previous treatment not reported. Concomitant treatment not reported.

2 lost to follow-up at 3 months in SGB group

Baseline pain (0 - 100 scale) mean (SD):

Stellate ganglion block group: 70.5 (27.36)

IVRB guanethidine group: 65 (25.46)

Medico-legal factors: not reported


InterventionsSGB (n = 10) versus IVRB guanethidine block (n = 9); treatment period of 16 days

SGB: Bupivacaine (0.5%) 15 ml

No. of blocks: 8 (1 every other day for 16 days)

Evaluation of adequacy of block? Skin temperature, plethysmographic wave

IVRB guanethidine (20 ml), heparin (500 μl), isotonic saline (25 ml)

No. of blocks: 4 (every 4 days)


OutcomesPain: 100 mm linear scale (specific details not reported)

Pain measured at baseline and post-treatment at 15 minutes, 60 minutes, 24 hours, 48 hours, 1 month and 3 months.

Adverse events only mentioned in discussion (alludes to none in either group)


Country of originItaly


Study aimTo compare the effects of regional IVRB with guanethidine with stellate ganglion blocks in people with severe RSD following peripheral nerve injury of the upper limb.


NotesConflicts of interest not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "patients were randomly allocated to two groups"

Comment: Method of randomisation not reported.

Allocation concealment (selection bias)Unclear riskAllocation concealment not reported

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipant blinding not reported. The interventions are likely to be distinguishable. Unsure if participants aware of study hypothesis.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAssessor blinding not reported.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data post-treatment and one-month follow-up. 3 months: 2/10 missing from SGB group, no missing data for IVRB group.

Selective reporting (reporting bias)Low riskAll outcomes listed in methods were reported in the results.

Adequate sample size?High riskn = 19; n = 10 stellate ganglion block group, n = 9 regional IV guanethidine

Adequate duration of follow up?Low riskFollow-up of 3 months

Free of other bias?High riskSGB group had a significantly shorter duration of symptoms than the IVRB guanethidine group (mean [SD]: 6.55 [3.94] months versus 17.55 [14.9] months; P < 0.05) and were significantly older (mean [SD]: 52.33 [5.04] years versus 42.77 [4.65] years; P < 0.01).

Carroll 2009

MethodsRCT cross-over


Participantsn = 9

Lower limb CRPS-I, with duration of pain of at least 6 months, spontaneous pain rating > 6/10, unsuccessful therapy with at least 2 non-opioid medications (for neuropathic pain), at least a 50% reduction in pain for > 5 hours but < 2 weeks from a previous lumbar sympathetic injection.

Inciting events: tarsal tunnel surgery n = 1, bunionectomy/cast n = 1,  crush injury n = 1, plantar fasciectomy n = 1, foreign body removal n = 1, ankle arthroscopy n = 1, ankle fracture/cast n = 1, metatarsal fracture n = 1, back surgery n = 1

Diagnostic criteria: IASP (Merskey 1994)

Medico-legal factors: not reported.

Age mean (range) 49.4 (38 - 67)

Gender: 1 man

Duration of pain (years) mean (range) 3.8 (2 - 14)

Baseline pain levels (whole group) mean (range) 7.2 (4.7 - 8.9)

Concomitant treatments: Not reported but participants asked not to cease existing therapies, but not to start new therapies during study period.


InterventionsLumbar sympathetic blocks:

Anterolateral border of L2 vertebral body, fluoroscopy guided.

Active: 10 ml of 0.5% bupivacaine with an added 75 units Botulinum toxin-A
Control: 10 ml of 0.5% bupivacaine.


OutcomesPrimary outcome: time to analgesic failure (time for pain to return to baseline level)

Daily pain intensity - 10 cm VAS, measured for 7 days prior to first injection and recorded daily until participants reported their pain returned to baseline or 1 month (whichever was longer).

Adverse events reported.


Country of originUSA


Study aimTo determine whether adding BTA to lumbar sympathetic blockade increases the duration of analgesia


NotesAuthors declared that they had filed a patent for BTA in sympathetic blocks.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly assigned to which injection they received first".

Comment: Method of randomisation not described

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "All physicians and patients involved in the study were blinded to which injection contained botulinum toxin A. Data were not unblinded for any patient until the study was completed, and no interim analyses were performed"; "in the crossover injection, the patient received an identical injection"

Comment: Injections were identical and participants blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: as above.

Comment: Self-reported outcomes and participants were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk2/9 participants did not complete the study (one due to technical issues related to the block - malpositioning of the needle - and one because outcome forms were not returned). Only 1 participant received Botox first and this participant dropped out.

Due to complete blinding and use of a cross-over study design, the effect that this drop-out has on the results is unclear.

Selective reporting (reporting bias)Unclear riskFull data not presented for the secondary end point (VAS pain scores over time); comparison of within-injection group change over time provided, but comparison of between-injection group differences not provided.

Are data clearly free of carry-over effects? (cross-over designs only)Low riskQuote: "patients were eligible for their crossover injection 1 month after they reported their pain had returned to baseline"

Comment: 1 month washout period observed, after pain had returned to baseline levels

Adequate sample size?High riskn = 9

Adequate duration of follow up?Unclear riskQuote: "Patients continued to record daily VAS until they reported their pain had returned to baseline or 1 month, whichever was longer"

Comment: Follow-up was observed until pain returned to baseline levels - for some this was only 4 weeks.

Free of other bias?Low riskCross-over study design ensured similarity between groups; participants allowed to continue current medications but could not start new medications.

Meier 2009

MethodsRCT cross-over


Participantsn = 23

Children with unilateral lower limb CRPS (type I or II)

Diagnostic criteria (Stanton-Hicks 1995)

Gender: 3 boys

Age: mean(SD) 14.4 (2.4) range 10 -18

Baseline pain levels:

Slight: Group 1, n = 3; Group 2, n = 5

Moderate: Group 1, n = 6; Group 2, n = 10

Severe: Group 1 n = 14, Group 2, n = 10

Duration of pain: median (IQR) 9 months (4.5 - 23)

Inciting events: sports injury n = 8, surgery n = 6, accidental trauma n = 8, unable to recall n = 1.

Previous treatment: failed to respond to a 6-week trial of aggressive physical, bio-behavioural and pharmacological therapies.

Concomitant treatments: use of NSAIDs withheld for 2 days prior to trial intervention.

Medico-legal factors: not reported.


InterventionsIV lidocaine + placebo sympathetic block (Group 1) versus IV placebo + lidocaine sympathetic block (Group 2).

Lumbar sympathetic block: percutaneous lateral paravertebral approach at anteromedial border of L 2/3 vertebral bodies. Fluoroscopy guided. Active: 1% lidocaine (0.1 ml/kg up to a maximum possible total of 6 ml) Placebo: saline 0.9% (0.1 ml/kg)

IV lidocaine: 1% lidocaine (0.1 ml/kg up to a maximum possible total of 6 ml). Placebo: saline 0.9% (0.1 ml/kg)

No. of blocks performed:1 for each condition

Evaluation of adequacy of block: YES. Semi-objective measures of increased ipsilateral skin temperature and decreased evoked pain.


OutcomesGlobal 4-point verbal pain scale (none, slight, moderate, severe)

Colour analogue scale for spontaneous pain.

Both pain outcomes were measured pre- and 30 minutes post-intervention.

Adverse events measured.


Country of originUSA


Study aimTo compare the efficacy of lidocaine administered by lumbar sympathetic or IV route


NotesGrants and financial support reported but no clear statement relating to conflicts of interest.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "We randomized the patients using a pseudo-random number generator"

Comment: Probably done.

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "A single blinded researcher performed all bedside examinations and computerized quantitative sensory testing"; "Neither the investigator who performed and collected the pain assessment data in all patients nor the patients were aware of the nature of the solutions injected"

Comment: Indistinguishable treatments and participants blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: as above

Comment: Single assessor blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data; n = 23 in all tables.

Selective reporting (reporting bias)Low riskAll prespecified outcomes (in methods) adequately reported in the results.

Are data clearly free of carry-over effects? (cross-over designs only)Low riskQuote: "two-paired injections were administered in two sessions 12 h apart to allow adequate systemic washout of lidocaine"; "The volume of lidocaine 1% was 0.1ml/kg and did not exceed a total of 6ml, which is minimally adequate to achieve satisfactory sympathetic ganglia blockade"; "No carryover effects were found for any variable of spontaneous and evoked pain assessment"

Comment: 12-hour washout period, minimal required dose used, carry-over effects investigated and not found

Adequate sample size?High riskn = 23

Adequate duration of follow up?High riskOnly 30 minutes post-injection follow-up

Free of other bias?Low riskCross-over study design ensured similarity between groups. Outcome assessment timing identical between treatment.

Nascimento 2010

MethodsRCT, parallel


Participantsn = 43

Gender:

Group 1 (n = 14): 1 male

Group 2 (n = 15): 1 male

Group 3 (n = 14): 1 male

Age mean (range):

Group 1: 37.7 (27 - 54)

Group 2: 38.6 (25 - 50)

Group 3: 39 (27 - 50)

Upper extremity CRPS

Diagnostic criteria: IASP (Merskey 1994)

Duration of pain (months) mean (range):

Group 1: 24.2 (3 - 72)

Group 2: 24.2 (8 - 72)

Group 3: 22.3 (2 - 48)

Baseline pain intensity (mean (SEM):

Group 1: 8.7 (0.3)

Group 2: 8.7 (0.3)

Group 3: 8.3 (0.3)

Inciting event:

Repetitive strain injury n = 18, carpal tunnel syndrome n = 11, late post surgical pain n = 8, fracture and long lasting immobilisation n = 3, stab wound n = 2, unknown n = 1.

Previous treatment for CRPS: unsuccessful use of tricyclic antidepressants, gabapentin, opioids or anti-convulsants.

At admission all free of drugs.

Medico-legal factors: not reported


InterventionsGroup 1: SGB, anterior paratracheal approach, fluoroscopy-guided, 70 mg 1% lidocaine

Group 2: SGB, identical approach,70 mg 1% lidocaine + 30 μg clonidine

Group 3: IVRB 7.0 ml solution 1% lidocaine with 1 μg/kg clonidine. Tourniquet pressure released 30 mins later.

Evaluation of adequacy of block?: YES, temperature checked

No. of blocks: 5, x 1 weekly


OutcomesPain intensity 0 - 10 cm VAS (anchors "no pain" to "worst pain imaginable")

Pain was measured immediately before and soon after the end of each procedure. Pain intensity scored daily. Pain measured one week after the last procedure.

Duration of analgesia calculated as the interval between the end of the procedure and the time at which VAS ≥ 3 was recorded.

Adverse events reported.


Country of originBrazil


Study aimTo compare the efficacy of IVRB produced by combining lidocaine with clonidine, to that of SGB produced by the injection of lidocaine, alone or combined with clonidine, into the stellate ganglion, for the management of pain in people with upper extremity CRPS-I.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly assigned to one of three experimental groups"

Comment: Method of randomisation not described

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated that study was blinded nor whether participants were blind to the study hypotheses

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "Side effects and effectiveness of treatment were recorded by another author who was unaware of the procedure"

Comment: While side effects and effectiveness were recorded by a blinded assessor, the use of self-reported outcome in participants who may not have been blind to the study hypothesis is a possible risk of bias

Incomplete outcome data (attrition bias)
All outcomes
Low riskExcluded 2/45 with clear reasons and clear n reported for all graphs

Selective reporting (reporting bias)Low riskAdequately reported results for all prespecified outcomes (from methods section).

Adequate sample size?High riskn = 45; 15 participants per treatment group

Adequate duration of follow up?High risk1 week follow-up

Free of other bias?Low riskNo differences between groups for important prognostic factors, participants not taking any medication at inclusion, outcome assessment timing identical between groups.

Price 1998

MethodsQuasi-randomised controlled trial (cross-over)


Participants7 adults with CRPS I or II of upper or lower extremities (excluded if CRPS in multiple areas)

Diagnostic criteria: IASP (Merskey 1994)

n = 7 (3 lower extremity, 4 upper extremity pain)

Age: mean 42 years (SD: 11; range: 32 - 52)

Gender: 3 men

Duration of symptoms: mean of 3 years (SD: 2 years; range 18 months to 7 years)

Inciting event: trauma (n = 6), surgical (n = 1)

Medico-legal factors: not reported

Previous treatment: not reported

Concomitant treatment: All participants continued concomitant physical therapy and medications.


InterventionsActive condition:

Stellate ganglion blockade with lidocaine (15 ml of lidocaine 1%)

Lumbar sympathetic blockade with 15 ml 1% lidocaine (test solution) followed by 10 ml bupivacaine 0.125%

Evaluation of technical adequacy of block? YES - evaluated Horner's syndrome and surface skin temperature for stellate ganglion blocks. Nothing reported for lumbar blocks.

Control condition:

Stellate ganglion: 15 ml saline

Lumbar: 15 ml saline +10 ml saline

The blocks were separated by a period of 7 - 10 days.

Number of blocks: 1 for each condition


OutcomesPain intensity and pain unpleasantness (0 - 10 VAS).

Pain outcomes measured every 15 minutes for 1.5 hours prior to injection and every 15 minutes for 1 hour following injection. Pain outcomes then rated 4 times a day (morning, mid-day, afternoon, evening) for 7 days post-injection.

Time to peak analgesia measured as the VAS unit difference between pre-inujection baseline pain rating and the lowest VAS rating in the first hour.

Duration of pain relief measured as the time it took for pain intensity to return to 50% of the difference between baseline and peak analgesic effect.


Country of originUSA


Study aimTo evaluate the diagnostic and therapeutic value of local anaesthetic sympathetic blocks


NotesAuthor confirmed the quasi-random allocation in correspondence


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Four patients received S first with LA block second, and the order was reversed for the remaining 3 patients"

Comment: Quasi-random process used, not truly random. Due to cross-over study design and successful blinding, we feel this presents an unclear risk of bias.

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Both the patient and the physician administering the sympathetic ganglia injections were blind with regard to the contents of the injecting syringe (S or LA) and with regard to whether skin surface temperature changes or Horner's syndrome occurred"; "The syringe was filled...by a third person who maintained the code for the contents of the syringes and the double-blind nature of the study"; "None of the 7 patients reported subjective differences between effects of S and LA blocks within the first hour after block. However, 2 patients correctly determined that they had received S injection because of the shorter duration of relief received."

Comment: Blinding completed and blinding success was formally assessed.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcomes were self-rated and participants were blinded to treatment group.

Incomplete outcome data (attrition bias)
All outcomes
Low risk2/7 participants missed all pain unpleasantness data but pain intensity data complete.

Selective reporting (reporting bias)High riskGroup results for pain unpleasantness scores not reported

Are data clearly free of carry-over effects? (cross-over designs only)Low riskProcedures separated by 7 - 10 days. Figures illustrate pain returned to baseline levels prior to next block.

Adequate sample size?High riskn = 7

Adequate duration of follow up?High risk7 days follow-up

Free of other bias?Low riskQuote: "Medication use and physical therapy were as similar as possible for the time periods following both saline and lidocaine blocks, and medications were not, as a rule, significantly adjusted during the study period."

Comment: Also, cross-over study design ensured similarity between groups for important outcomes and outcome assessment at same time periods.

Raja 1991

MethodsRandomised cross-over trial


Participantsn = 20, 10 upper limb, 10 lower limb

Mean age: 40 (range 20 - 57)

Gender not reported

Diagnosis of sympathetically maintained pain was "under consideration" based on clinical criteria (chronic pain and hyperalgesia to pain and/or cooling stimuli).

Mean duration of pain 37 months (range 6 - 120)

All participants had a prior history of traumatic or surgical injury of which 10 had one or more peripheral nerve injuries.

Previous treatment not reported.

Medico-legal factors not reported

Concomitant treatment not reported


InterventionsSympathetic blockade (stellate or lumbar) with bupivacaine versus IV phentolamine block

Sympathetic block:

Substance injected:0.25% bupivacaine hydrochloride (10 ml SGB, 20 ml lumbar)

Site of block:

Lumbar - anterolateral border of body of L2 or L3 vertebrae. Fluoroscopic guidance, single needle technique

Cervical - anterior paratracheal approach to SGB

No. of blocks: 1

Evaluation of technical adequacy of block?: YES - cutaneous temperature measures, sensory testing to exclude somatic nerve block

Phentolamine block: IV catheter

Substance injected:

300 - 400 ml lactated Ringers solution followed by basal infusion of 2 ml.kgh-1.h-1

1 or more boluses of normal saline (3 - 5 ml) to establish the presence of significant placebo responses then phentolamine at 3 - 8 minute intervals in increasing dose ranging from 1 - 10 mg up to a total of 25 or 35 mg


OutcomesIntensity of ongoing pain (0 - 100 VAS, Anchors "no pain" to "most intense pain imaginable")

Pain was rated every 5 minutes before, during, and after the interventions. Baseline pain measurements were made for at least 15 mins prior to the blocks. A subsample of patients was assessed at hourly intervals for several hours (sympathetic blockade, n=3; phentolamine, n=4).

Maximum pain relief: difference between the control (average of two consecutive pain ratings immediately prior to intervention) and the lowest postblock rating (average of two consecutive lowest pain ratings), expressed as a percentage of the control pain rating.

Adverse events reported.


Country of originUSA


Study aimTo determine if systematic α-adrenergic blockade with phentolamine can be used to diagnose SMP.


NotesFinancial support from NIH & Canadian MRC stated

2 patients excluded from analysis after achieving substantial pain relief with infusion of normal saline.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The sequence of the two sympathetic blocks was randomized such that half of the patients received the LASB first and the other half received the PhB first"

Comment: Method of randomisation not reported, so unclear risk.

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated whether participants/personnel were blind to the study hypothesis

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcomes were self-rated; not stated whether participants were blind to the study hypothesis

Incomplete outcome data (attrition bias)
All outcomes
High riskQuote: "Two patients had nearly complete relief of pain and hyperalgesia during the saline injection period prior to the administration of propranolol. These two patients were excluded from further analysis"; "In four of the nine SMP patients, the duration of pain relief after PhB was followed for several hours"; "In three of the four above-mentioned SMP patients, the duration of pain relief after LASB also was followed for 4-8 h"

Comment: 2/20 were excluded (10%), duration of pain relief not followed up for the entire group

Selective reporting (reporting bias)Low riskReported on all prespecified outcomes

Are data clearly free of carry-over effects? (cross-over designs only)Unclear riskNot reported; no clear washout period reported (range for 1 to 40 days)

Adequate sample size?High riskn = 20

Adequate duration of follow up?High riskQuote: "the duration of pain relief after PhB was followed for several hours...varied from 3 to 10 h"; "the duration of pain relief after LASB also was followed for 4-8 h"

Comment: Maximum follow-up of 10 hours postintervention (ranged from 3 - 10 hours postintervention)

Free of other bias?Low riskCross-over study design ensured similarity between groups and outcome assessment timing was identical.

Rodriguez 2005

MethodsRCT, parallel design


Participants82 participants with upper limb CRPS (Type I or Type II) with presence of pain mediated by the sympathetic nervous system (defined as a decrease in resting pain by 50% with a stellate ganglion block).

Diagnostic criteria: IASP 1994

71.4% of CRPS cases were secondary to accidental or violent trauma and 18% occurred following surgical procedures.

2 active intervention groups:

1. SBG group: n = 41, mean age: 44.1 years, gender: 36.6% men, 75.6% CRPS-1, 68.3% right hand affected, 14.6% had a compensation claim, duration of symptoms: 253.7 days

2. Control group: n = 41, mean age: 46.1 years, gender: 46.3% men, 70.7% CRPS-1, 46.3% right hand affected, 24.4% had a compensation claim, duration of symptoms: 213.4 days

Previous treatment: participants were excluded if they had previous stellate ganglion blocks; no other previous treatment reported.

Concomitant treatment: those receiving stellate ganglion blockade also received physical therapy and pharmacological treatment


InterventionsSGB, physical therapy and pharmacological treatment vs physical therapy and pharmacological treatment

SGB Group:

Site of block: paratracheal at the height of the cricoid cartilage

Number of blocks: 5

Type of substance injected: 10 cc of volume with equal parts of 2% lidocaine and 0.5% bupivacaine

Evaluation of technical adequacy: Increase in temperature of at least 1°C of the hand and face (affected side) and the presence of Horner's syndrome (ptosis of the upper eye lid and conjunctivitis)

Control group:

Received physical therapy and pharmacological treatment.


Outcomes1. Pain intensity (VAS). Measured at baseline, one month and two months. Exact follow-up time appears to be variable among participants (ie, followed for more than two months in some).

2. Therapeuctic efficacy: Number of participants with at least 50% reduction in the pain Measured at 2 months post-intervention.

3. Efficacy: (incidence of pain in control group - incidence of pain in the SGB group)/incidence of pain in the control group * 100

4. Absolute risk reduction (incidence of pain in control group - incidence of pain in the intervention group). Measured at 2 months post-intervention.

5. NNTB = 1/ARR (calculated at 2 months post-intervention)

6. Relapse (return of pain to less than 50% reduction or return of pain to baseline levels or above); determined at 2 months post-intervention.


Country of originColombia


Study aimTo determine the analgesic efficacy of the stellate ganglion blockade (SGB) in the alleviation of pain mediated by the sympathetic nervous system in patients with Complex Regional Pain Syndrome.


NotesThis is the first published study by Rodriguez. There are 2 other published studies and one IASP abstract that use an identical study design. It is unclear if all the studies represent the same base participant population. We attempted to contact the authors 3 times with no success.

This study was translated and interpreted by a researcher fluent in Spanish. The study author, TS, worked with the researcher to fully interpret and score.

Funded by Colciencias and the Universidad Libre Seccional Cali. No conflict of interest stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomized"

Comment: Method of randomisation unclear

Allocation concealment (selection bias)Low riskOpaque envelopes used; randomly given to each participant.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "double blind"

Comment: Probably not. Index and control groups are not indistinguishable and success of blinding was not tested.

Blinding of outcome assessment (detection bias)
All outcomes
High riskThe investigator was reported to be blinded; however, outcomes were self-reported and participants were likely not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskParticipants that dropped out or underwent surgery were excluded from the analysis. The number of excluded participants per group is not reported.

Selective reporting (reporting bias)High riskNo pain scores were given and time to relapse was unclear

Adequate sample size?High riskn = 82 (41 in each group)

Adequate duration of follow up?Low riskFollow-up of 2 months

Free of other bias?High riskNo baseline data given on pain intensity; unsure if groups were similar at baseline.

Toshniwal 2012

MethodsRCT, parallel design


Participants33 people diagnosed with CRPS type I of the upper extremity (diagnostic criteria IASP 1999), which had lasted at least 3 months and was refractory to medical management. People receiving any interventional procedure for the condition were excluded.

Participants were randomised to one of two active intervention groups:

1. Continuous stellate ganglion block (CSG)

n = 19 (1 excluded due to catheter dislodgement), mean age 44.33 years (SD: 13.6), 6 men, mean duration of pain: 8.8 months (SD 4.4).

2. Continuous infraclavicular brachial plexus block (CIBP)

n = 14 (1 excluded due to catheter dislodgement and 1 due to failure to follow-up after 2 weeks), mean age 42 years (SD 16.6), 7 men, mean duration of pain: 9.3 months (SD 2.8).

Both groups:

Inciting event: not reported.

Medico-legal factors: not reported

Previous treatment: not reported

Concomitant treatment: Physiotherapy (4 weeks), no change in medication.


InterventionsContinuous stellate ganglion block (CSG) versus continuous infraclavicular brachial plexus block (CIBP). Both groups received physiotherapy (as per recommendations from same physiotherapist) for 4 weeks. No change in regular medications in either group.

1. CSG block

Site: Stellate ganglion - 20 G IV cannula was inserted anterolaterally into the neck, lateral to the cricoid cartilage. Cannula inserted until the C6 tubercle was hit at which time the stylet was removed and the cannula vertically sutured to the skin. Cannula position confirmed via injection of 2 mL of radio-opaque dye under fluoroscopy.

Number of blocks: Continuous block for 7 days

Type/amount of anaesthetic: bolus of 10 mL (5 + 5 mL) 0.25% bupivacaine was injected. An elastomeric pump (solution of 0.125% bupivacaine 280 mL, delivering at 2 mL/hour) was attached to the catheter. Pump was changed on day 5.

Evaluation of technical adequacy: Measured temperature difference between arms (> 1.5°C temperature increase in the affected arm considered adequate sympatholysis) and degree of vasodilatation using plethysmography scores (where an increase in the waveform reading score by 2 was considered improved circulation secondary to sympatholysis/vasodilatation).

2. CIBP block

Site: Brachial plexus - identified using nerve stimulation by vertical approach and inserting a Contiplex D needle with catheter. Position was confirmed via injection of 3 cc of radio-opaque dye under fluoroscopy.

Number of block: Continuoue block for 7 days

Type/amount of anaesthetic: Bolus of 30 mL 0.25% bupivacaine was injected through the catheter. An elastomeric pump containing 0.125% bupivacaine 400 mL delivering at 5 mL/hour was connected to the catheter. Pump was changed on days 3 and 6.

Evaluation of technical adequacy: As above. Both groups had an increase in temperature of the blocked arm (vs contralateral hand) and improvement in circulation (at 30 mins); no difference between groups.


OutcomesNeuropathic pain scale - components analysed separately (intensity, sharp, hot, dull, cold, sensitive, itchy, unpleasant, deep pain, surface pain, and quality of pain). Scale was 0 (i.e., intensity, 0 = no pain) to 10 (i.e., intensity, 10 = most intense pain sensation imaginable).

Measured at 6 minutes, 30 minutes, 2 hours, 12 hours, and 24 hours, day 2, day 3, day 4, day 5, day 6, day 7, week 2, week 3, week 4.

Adverse events reported.


Country of originUSA


Study aimTo compare the efficacy of continuous stellate ganglion (CSG) block with that of continuous infraclavicular brachial plexus (CIBP) block in management of CRPS type I of upper extremity.


NotesThe authors acknowledged editorial support from 2 doctors from Wayne State University, Detroit. The authors declared that they have nothing to disclose and no conflict of interest.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "patients...were randomly assigned to receive CSG block or CIBP block using a computer-generated table of random numbers (50 numbers in two columns)"

Comment: Likely done.

Allocation concealment (selection bias)Low riskQuote: "Group allocations was concealed in sealed opaque envelopes that were not opened until patient consent had been obtained"

Comment: Likely done.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBoth active interventions but does not mention blinding

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcomes are self-rated, thus unclear risk due to uncertainty whether participants were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "Three patients were dropped from the study. One patient from each group was excluded from the study as their catheters became dislodged during the follow-up period, and one patient in the CIBP group was excluded because he failed to follow up after 2 weeks"

Comment: Drop-out rates < 20% (1 group had 1/19 drop out [5.3%] and 1 had 2/14 drop out [14.3%]). Similar reasons for drop-out.

Selective reporting (reporting bias)Low riskReports all outcomes and all between-group differences

Adequate sample size?High riskn = 18 (CSG), n = 12 (CIBP)

Adequate duration of follow up?Unclear risk4 weeks of follow-up

Free of other bias?Low riskGroups were similar on important prognostic factors.

Verdugo 1995

MethodsRandomized double blind cross-over study


Participants16 adults with CRPS of upper extremity. Symptoms of < 3 months duration.

Age, gender, previous treatments not reported.

CRPS diagnosis method not reported.

Inciting event: not reported

Concomitant treatments: not reported

Medico-legal issues: not reported


InterventionsStellate ganglion blockade with normal saline or with bupivacaine 0.125%


OutcomesIntensity of spontaneous pain (0-10 VAS) measured pre-block, 2 hours post-block and 48 hours post-block.

Significant response considered a reduction in pain by 50%.


Country of originChile


Study aimThere are no placebo-controlled studies showing a specific effect of this method (stellate ganglion blockade).


NotesThe abstract was published in the proceedings of a scientific meeting.
The author has not published the final results.

Financial support from Fondecyt Project No. 1940309 stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were randomly assigned"

Comment: Method of randomisation not reported

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "double blind"; "the patient was wearing sunglasses to prevent observation of Horner's syndrome"; "the anesthetist, who was not aware of which substance had been given"

Comment: Participants/personnel blinded to the nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-report outcomes and participants were blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs

Selective reporting (reporting bias)High riskResults for pain with movement outcome were not provided

Are data clearly free of carry-over effects? (cross-over designs only)Unclear riskInterventions were separated by a 1-week period, but long-lasting effect on pain was not measured, so it is unclear if participants returned to baseline levels of pain

Adequate sample size?High riskn = 16

Adequate duration of follow up?High riskFollow-up of 48 hours

Free of other bias?Low riskCross-over study design ensured similarity between treatment groups, outcome assessment timing identical

Wehnert 2002

MethodsRandomised, cross-over study


Participants29 participants with "persistent pain in the area of the upper or lower extremities". Used inclusion criteria of Campbell 1996: resting pain + 3/11 symptoms (e.g., changes to skin temperature)

Gender: 8 men

Age: 43 years (range of 23 - 64)

Based on a lack of temperature change in the affected limb with a local sympathetic blockade (n = 9) or a placebo response to saline (n = 1), only 19 participants were considered to have had a correctly performed sympathetic block and pain results were only presented for these 19 participants.

12 upper limb, 17 lower limb.

Mean duration of pain 21.3 months (minimum of 2 months, maximum of 15 years)

Previous treatment not specified

No difference in pain scores prior to the 2 interventions (Z = -0.540, P = 0.589)

Inciting event: post-surgical or post-traumatic (numbers not reported)

Previous treatment: Not reported

Medico-legal issues: Not reported

Concomitant treatment: Not reported.


InterventionsStellate ganglion blockade (cervical stellate ganglion in upper limb participants, sympathetic chain of lumbar spine for lower limb participants) versus IV phentolamine infusion.

Stellate ganglion blockade:

Substance injected: 0.1 mL bupivacaine 0.25%/cm plus 500 mL NaCl 0.9%

Site of block:

Number of blocks: 1

Evaluation of technical adequacy of block?: YES - cutaneous temperature measures

Control intervention: Intravenous phentolamine infusion

Substance injected:0.5 mg phentolamine/kg for 15 minutes plus 500 mL NaCl 0.9%.

Site of intervention: provided to a non-affected limb.

Number of interventions: 1


OutcomesVAS pain intensity (0 - 100), measured at baseline and then hourly for 8 hours.

A significant improvement was defined as reduction of pain of at least 50%.


Country of originGermany


Study aimTo determine whether the phentolamine test is as suitable as sympathetic blockade in diagnosing cases of sympathetically maintained pain.


NotesWhile the aim of the study was to diagnose SMP, the data available also provide us with pain outcomes for a local stellate ganglion blockade versus IV phentolamine infusion in participants with SMP, allowing for inclusion in the present review.

This study was translated and interpreted by a researcher fluent in German. The study author, TS, worked with the researcher to fully interpret and score.

No statement of financial support or conflict of interest.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomized study"

Comment: method of randomisation not reported

Allocation concealment (selection bias)Unclear riskNo information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported as to whether participants were blinded to the study aims

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported as to whether outcome assessment was blinded

Incomplete outcome data (attrition bias)
All outcomes
High riskRandomisation was completed prior to exclusion of 10 participants, therefore 34% drop-out rate.

Selective reporting (reporting bias)Low riskAll prespecified outcomes adequately reported

Are data clearly free of carry-over effects? (cross-over designs only)Low riskPain scores prior to the interventions were not significantly different.

Adequate sample size?High riskn = 19

Adequate duration of follow up?High riskFollow-up of 8 hours

Free of other bias?Low riskCross-over study design ensured similarity between participant groups, pre-intervention pain scores similar, outcome assessment timing identical.

Zeng 2003

MethodsRCT, parallel


ParticipantsShoulder-hand syndrome following stroke.

Diagnostic criteria not reported.

Duration of symptoms; described as "in the early stages of SHS complicated with paralysis"

n = 60

Gender: 42 men

Age range: 38 - 71

Previous treatment not specified

Baseline pain mean (SD):

SGB + rehab group: 6.95 (3.24)

Rehab-only group: 6.85 (3.24)

Medico-legal factors not reported.

Concomitant treatments: not reported.


InterventionsStellate ganglion block + rehabilitation versus rehabilitation only.

SGB: anterior entry, transverse process of C7, agent, dose not reported.

Rehabiliation details: reports "comprehensive treatment" eliminating causes of oedema, avoid weight loading of limb, avoid limb trauma, remove factors causing shoulder pain, movement exercises, joint mobilisations, ice therapy, physical therapy


OutcomesPain VRS (0 = no pain, 2 = little pain, 4 = often pain but mild or occasional but severe (sic), 6 = severe pain but tolerable, 8 = continuous pain and intolerable, 10 = severe pain that couldn't be touched).

Pain was measured before treatment and at 10 days and 20 days post-treatment.


Country of originChina


Study aimEffect of stellate ganglion is observed on base of comprehensive rehabilitation treatment (sic)


NotesNo statement of financial support or conflict of interest.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly divided into two groups"

Comment: method of randomisation not reported

Allocation concealment (selection bias)Unclear riskAllocation concealment not reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskIndex and control groups are not indistinguishable and success of blinding was not tested.

Blinding of outcome assessment (detection bias)
All outcomes
High riskParticipant-rated outcomes; participants not blinded (as above).

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs.

Selective reporting (reporting bias)Low riskAll prespecified outcomes adequately reported on.

Adequate sample size?High riskn = 60 (30 in each group)

Adequate duration of follow up?Unclear risk20 days follow-up

Free of other bias?Low riskQuote: "All patients were in early stage of SHS complicated with paralysis"; "there weren't statistical differences at age, sex, rehabilitation kind"

Comments: No difference between groups in age, gender, rehabilitation and duration of symptoms; outcome assessment timing identical

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ackerman 2006Not randomised.

Arias 1989Not randomised.

Catala 1994Sympathetic blockade versus intravenous lidocaine for postherpetic neuralgia

Dellemijn 1994Sympathetic blockade versus phentolamine infusion.

Erickson 1993Not randomised.

Farcot 1990Not randomised.

Fukusaki 1995Nerve blocks (including sympathetic blocks) for cervical radiculopathy.

Garrido 2005Not randomised.

Geurts 2006Not randomised.

Glynn 1993Not randomised

Hartrick 2004Not randomised.

Linson 1983Not randomised.

Malmqvist 1992Not randomised.

Perrigot 1982Not a local sympathetic block.

Quevedo 2005Not randomised.

Rodriguez 2006Identical study design to Rodriguez 2005 (included) and recruited from the same sources and time period therefore it seems that this study may have recruited the same population (participant demographics are also very similar). Unable to contact authors to confirm whether these were different populations of participants.

Rodriguez 2008Identical study design to Rodriguez 2005 and Rodriguez 2006, just a larger sample of participants (n=114). Therefore it seems that this study may be using the data from the original studies. Unable to contact authors to confirm whether these were different populations of participants.

Salinas Cerda 1997Could not retrieve this study.

Schurmann 2001Not randomised.

Steinbrocker 1953Not randomised.

Tran 2000Sympathetic blockade plus iohexol versus sympathetic blockade plus saline; evaluating the effect of the contrast agent iohexol.

Wang 1985Not randomised.

Yucel 2009Not randomised.

 
Characteristics of ongoing studies [ordered by study ID]
Rocha 2012

Trial name or titleThoracic sympathetic block for the treatment of complex regional pain syndrome I of the upper limb

MethodsRCT parallel

ParticipantsEstimated n = 60

CRPS (IASP 1994 criteria)

Age 18 years or older

Pain scores > 5 on 0 - 10 VAS

Poor outcome to (?prior) treatment (< 50% improvement in pain VAS scores)

InterventionsActive: Thoracic sympathetic blockade with ropivacaine (5 ml, 0.75%) and triamcinolone (2%)

Control: Dorsal subcutaneous delivery of the same active agent.

OutcomesAnalgesia after block at 1 month (McGill pain questionnaire, Brief pain inventory, DN4 questionnaire, VAS)

Starting dateJanuary 2010

Contact informationRoberto O Rocha MD

email: contato@drrobertorocha.com.br

NotesAttempted to contact author, but email address no longer works.

 
Comparison 1. Local anaesthetic block versus normal saline

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of patients who achieved at least 50% of pain relief246Risk Ratio (M-H, Random, 95% CI)1.18 [0.76, 1.84]

 
Table 1. Budapest criteria: diagnostic criteria for Complex Regional Pain Syndrome

To make the clinical diagnosis, the following criteria must be met:

 

1. Continuing pain, which is disproportionate to any inciting event

 

2. Must report at least one symptom in three of the four  following categories:

·          Sensory:

                  Reports of hyperaesthesia and/or allodynia

·          Vasomotor:

                  Reports of temperature asymmetry and/or skin colour changes and/or skin colour asymmetry

·          Sudomotor/Oedema:

                  Reports of oedema and/or sweating changes and/or sweating asymmetry

·          Motor/Trophic:

                  Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes

                  (hair, nail, skin)

 

3. Must display at least one sign at time of evaluation in two or more of the following categories:

·          Sensory:

                  Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic

                  pressure and/or joint movement)

·          Vasomotor:

                 Evidence of temperature asymmetry (> 1°C) and/or skin colour changes and/or asymmetry

·          Sudomotor/Oedema:

                 Evidence of oedema and/or sweating changes and/or sweating asymmetry

·          Motor/ Trophic:

                 Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes

                 (hair, nail, skin)

 

4. There is no other diagnosis that better explains the signs and symptoms

 

 For research purposes, diagnostic decision rule should be at least one symptom in all four symptom categories and at least one sign (observed at evaluation) in two or more sign categories. A sign is counted only if it is observed at time of diagnosis.