Nie 2015.
Methods | RCT Approved by the ethics committee and written informed obtained Setting: China Funding: governmental Open reduction and internal fixation surgery with the antirotation proximal femoral nail technique |
|
Participants | 104 participants scheduled for open reduction of hip fracture Excluded: neuropathy involving lower extremities, bladder dysfunction, coagulopathies, known allergy to amide local anaesthetic drugs or opioids, inability to co‐operate, psychological disorders or linguistic difficulties that could interfere with pain assessment |
|
Interventions |
Treatment group: fascia iliaca block (n = 51) Control treatment: intravenous patient‐controlled analgesia (n = 53) General anaesthesia with fentanyl, remifentanil, propofol and atracurium for surgery and flurbiprofen 40 mg at completion of surgery, plus acetaminophen and dihydrocodeine or morphine on request as rescue analgesia for all participants |
|
Outcomes | Pain at 2, 4, 6, 12, 24 and 48 hours after surgery (taken as at rest) Acute confusional state (time point unspecified, participants screened daily; length of hospital stay 23 and 21 days for fascia iliaca and IV groups, respectively) Opioid consumption up to 48 hours Participant satisfaction (92.5% of participants receiving a fascia iliaca block were satisfied vs 94.3% of participants receiving IV analgesia) |
|
Notes | Additional information received from study authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned according to a computer‐generated random number table" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "Blinding could not be conducted due to differences in the analgesia procedures and infusion pumps used" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "Blinding could not be conducted due to differences in the analgesia procedures and infusion pumps used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Patients who underwent the full protocol were included in the analysis" 2 participants withdrawn from fascia iliaca group owing to catheter failure |
Selective reporting (reporting bias) | Unclear risk | All results mentioned in methods section given in results section, except preoperative and postoperative mini‐mental state examination. We contacted study authors who informed us that Mini Mental tests were not "collected" |
Other bias | Unclear risk | Groups well balanced. Prophylaxis against nausea and vomiting given to IV group only Not in intention‐to‐treat |