Chan 2007.
Methods | RCT, parallel design | |
Participants | 188 patients, ASA I ‐ III, scheduled for hand surgery Exclusion criteria: local anaesthetic allergy, local infection, coagulopathy, neurological upper limb disorder, psychiatric or cognitive disorder, history of substance abuse or opiate use | |
Interventions | Ultrasound (n = 64) versus ultrasound + nerve stimulation (n = 62) versus nerve stimulation (n = 62) Axillary brachial plexus block; 3 nerves targeted individually in each group (radial, ulnar, median); all groups received 21 ml 2% lidocaine with 1:200,000 epinephrine and 21 ml 0.5% bupivacaine (14 ml around each nerve) Ultrasound: linear 5 ‐ 12 MHz probe (Philips HDI 5000); endpoint ‐ local anaesthetic spread around each nerve Nerve stimulation (Stimuplex): pulse duration 0.1 msec, frequency 2 MHz; endpoint ‐ stimulation at < 0.5 mA Ultrasound + nerve stimulation: needle positioned with ultrasound, further needle positioning to obtain stimulation at < 0.5 mA; endpoint ‐ circumferential spread of local anaesthetic |
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Outcomes |
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Notes | Multiple practitioners ‐ experience in technique not given, although some anaesthetists and some fellow/resident anaesthetists who were supervised Registered in clinicaltrials.gov |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number table |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes, but no further details |
Blinding of participants and personnel (performance bias):adequacy of block, need for supplementation | High risk | Not possible to blind anaesthetist |
Blinding of participants and personnel (performance bias):Complications | High risk | Not possible to blind anaesthetist |
Blinding of participants and personnel (performance bias): time outcomes | High risk | Not possible to blind anaesthetist |
Blinding of participants and personnel (performance bias): Patient discomfort | High risk | Not possible to blind anaesthetist, although use of "sham" equipment in order to ensure participant blinding |
Blinding of outcome assessment (detection bias): adequacy of block, supplementation of block | High risk | Need for rescue block assessed by anaesthetist who was not blinded |
Blinding of outcome assessment (detection bias): Complications | Unclear risk | No details of who assessed this, possibly anaesthetist |
Blinding of outcome assessment (detection bias): time outcomes | Unclear risk | Assessed by an independent observer, although unclear whether blinded |
Blinding of outcome assessment (detection bias): Patient discomfort | Low risk | Assessed during follow‐up telephone conversation ‐ participant blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | 30 participants (14%) not included as surgery commenced before 30‐minute assessment. Still possible to collect some outcome data for these participants |
Selective reporting (reporting bias) | Low risk | Protocol details published in clinicaltrials.gov. NCT 00221884. Outcomes appear to be reported |
Baseline characteristics | Low risk | Age, gender, weight, height, BMI, surgical time. All comparable |
Funding sources | High risk | Funding sources reported, to include supply of ultrasound equipment by manufacturers |
Operator expertise | High risk | Some blocks performed by supervised residents, which would have increased time to perform block and would introduce bias for this outcome |