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. 2017 May 11;2017(5):CD001159. doi: 10.1002/14651858.CD001159.pub2

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)
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
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)
Outcomes Pain scores at 15 minutes after the block
Opioids during 4 hours after the block
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 All outcomes Low risk One participant withdrawn from each group (38 randomized and 36 analysed)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