Danelli 2012.
Methods | RCT, parallel design | |
Participants | 50 participants, ASA I ‐ III, scheduled for elective coracoacromial ligament repair Excluded: < 18 yrs, > 85 yrs, unable to express informed consent, with known allergy to study medications, chronic opioid use, ipsilateral upper limb neurological deficits, or contraindications to continuous block placement |
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Interventions | Ultrasound versus nerve stimulation. Interscalene brachial plexus block for nerve roots of brachial plexus; blocked with 20 ml 1% lidocaine Ultrasound: 10 – 12 MHz linear probe (LOGIQ E), in‐plane approach; endpoint ‐ direct visualization of LA spread around nerve roots. Catheter inserted after injection of LA Nerve stimulation: pulse duration 0.2 ms, initial current 1 mA, frequency 2 Hz; endpoint ‐ stimulation of deltoid muscle motor responses at 0.5 mA. Stimulating perineural catheter was then inserted through the needle and advanced to maintain the adequate motor response at ≤ 0.4 mA. LA injected in increments |
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Outcomes |
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Notes | 2 practitioners experienced in both techniques Registered in clinicaltrials.gov No numerical data presented for supplementation rate ‐ "There were no differences in the...requirements for GA" No denominator figures provided. Email request sent to authors, but as yet no reply. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence of random numbers |
Allocation concealment (selection bias) | Unclear risk | “sealed envelope technique” but no further details given |
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 |
Blinding of outcome assessment (detection bias): adequacy of block, supplementation of block | Unclear risk | No details of who assessed this outcome |
Blinding of outcome assessment (detection bias): Complications | Unclear risk | No details of who assessed this outcome |
Blinding of outcome assessment (detection bias): time outcomes | Unclear risk | Some outcomes recorded by a nurse, but no details as to whether nurse was blinded |
Blinding of outcome assessment (detection bias): Patient discomfort | Unclear risk | No details of whether participant blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | Low risk | Protocol details published in clinicaltrials.gov. NCT 00702416. Outcomes appear to be reported |
Baseline characteristics | Low risk | Comparable |
Funding sources | Low risk | None apparent |
Operator expertise | Unclear risk | Only 2 practitioners, both experienced in both techniques |