Spansberg 1996.
Methods | RCT Approved by the ethics committee and informed consents obtained Setting: Denmark Funding: unspecified |
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Participants | 20 participants with a hip fracture surgically treated Mean age: 81 years (range 58‐91) Percentage female: unclear Lost to follow‐up: none | |
Interventions | All participants had spinal anaesthesia with 3.5 mL 0.5% bupivacaine
Postoperatively, participants received:
Treatment group: femoral nerve block with 0.4 mL/kg bolus of 0.5% bupivacaine, then infusion of 0.14 mL/kg/h 0.25% bupivacaine for 16 hours (n = 10) Control group: saline infusion for 16 hours of same volume of fluid (control) (n = 10) Regular aspirin administration and IM morphine on demand |
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Outcomes | Opioids used during first 18 hours after surgery No haematomas at the site of femoral catheters. Length of follow‐up unspecified |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized by a computer after surgery |
Allocation concealment (selection bias) | Low risk | Adequate |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled study: participants, recovery staff and observers were blind to the solution used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo‐controlled study: participants, recovery staff and observers were blind to the solution used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None lost to follow‐up Nine of 10 participants receiving bupivacaine were analgesic to pin prick in the distribution of all 3 nerves. The other participant was analgesic only in the distribution of the lateral femoral cutaneous nerve of the thigh |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced |