Cuvillon 2007.
Methods | RCT Approved by the ethics committee and written informed consents obtained Setting: France Funding: charity |
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Participants | 62 participants with a hip fracture undergoing surgery.
Mean age: 82 years (range not stated).
Percentage female: 86%. Arthroplasty: 58% Lost to follow‐up: not stated Excluded: more than 72 between fracture and surgery, weight < 40 kg, ASA physical status > IV, neurological disease (alcoholic or diabetic), allergy or contraindication to regional anaesthesia, severe hepatic or renal dysfunction, Mini Mental score < 15/30 |
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Interventions |
Treatment group: continuous femoral nerve block. Nerve stimulator, 0.3 to 0.5 mA, catheter introduced 10 to 15 cm past needle tip and loaded with 30 mL of lidocaine 1.5% plus epinephrine. Infusion of 0.2% ropivacaine at 10 mL/h for 48 hours (n = 21) Control groups: intravenous propacetamol 2 G 6‐hourly (n = 21) or subcutaneous morphine 0.05 mg/kg 4‐hourly (n = 20) Propacetamol and morphine before surgery, spinal anaesthesia for surgery for all participants. Treatment group and propacetamol group participants could also receive morphine after surgery if needed |
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Outcomes | Pain scores at 8, 24 and 48 hours after surgery Number of participants who required additional opioids during first 48 hours after surgery Confusion/somnolence Transfused Pressure sores Mortality at 6 months Cost of analgesic regimens |
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Notes | Length of follow‐up: 6 months Study authors contacted 22 May 2015; no reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized trial: use of numbered envelopes |
Allocation concealment (selection bias) | Low risk | Randomized trial: use of numbered envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None lost to follow‐up Failed blocked excluded, but no immediate failed block. Four catheter dislodgements; these participants were kept in the analysis (intention‐to‐treat) |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Unclear risk | Groups well balanced except for delay between admission and surgery (median 40 hours in femoral catheter group and 21 and 23,5 hours in the 2 control groups) |