Beaudoin 2013.
Methods | RCT Approved by the ethics committee and written informed consents obtained Setting: United States of America Funding: charity Registered at ClinicalTrials.gov (Identifier NCT01701414) |
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Participants | 36 participants Eligible: aged ≥ 55 years, radiographically proven femoral neck or intertrochanteric fracture, normal lower extremity neurovascular examination, able to consent and actively participate in the study, moderate to severe pain (numerical pain rating score 5) at time of enrolment Excluded: known international normalized ratio > 3.0, prior femoral artery vascular surgery on the same side as the fracture, other significant trauma, hypoxia (pulse oximetry < 92%), hypotension (systolic blood pressure < 100 mm Hg), known hypersensitivity to local anaesthetics or morphine |
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Interventions |
Treatment group: ultrasound‐guided femoral nerve block plus subcutaneous morphine (n = 18) Control group: sham‐injection (3 mL of saline under ultrasound probe over 5 minutes) plus subcutaneous morphine (n = 18) |
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Outcomes | Pain scores at 15 minutes after the block Opioids during 4 hours after the block |
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Notes | One participant in the SC group had an episode of rapid atrial fibrillation requiring diltiazem, but this participant had a history of chronic atrial fibrillation. No other adverse events (respiratory depression, hypotension, nausea or vomiting) were noted during the study period, and no other adverse events were reported to study investigators | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | After consent, participants were randomized by sequentially numbered cards in sealed envelopes Internet‐based programme with a 1:1 allocation ratio performed by the research department co‐ordinator, who was not involved in enrolment or data collection |
Allocation concealment (selection bias) | Low risk | After consent, participants were randomized by sequentially numbered cards in sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Blinded" with sham injection |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Blinded" with sham injection |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant withdrawn from each group (38 randomized and 36 analysed) Two patients enrolled (1 in each arm) dropped out after randomization but before the study procedure. No reason provided |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced |