Gille 2006.
Methods | RCT Approved by the ethics committee and informed consents obtained Setting: Germany Funding: corresponding study author had no relationship with any mentioned product nor competitors, classified as departmental resources |
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Participants | Orthopaedic hospital in Leipzig, Germany
100 participants with a hip fracture
Mean age: 80 years (range 35‐103)
Percentage female: 77%
Lost to follow‐up: none Excluded: < 18 years old, uncooperative, contraindications to regional anaesthesia or drugs used in the protocol, long‐term use of opioids and/or opioid dependence, history of ulcers, multiple trauma, absence of consent, anaesthetist inexperienced (fewer than 5) with the technique |
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Interventions |
Treatment group: femoral nerve block with catheter inserted at the time of admission (stitched in place) using 40 mL 1% prilocaine, then 30 mL 0.2% ropivacaine 6‐hourly (n = 50) Control group: no injection (n = 50) Operated 14 hours after admission. All participants had ibuprofen every 8 hours after surgery |
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Outcomes | Pain score on a scale of 1 to 5 (least pain level 1) at rest and passive movement (30 degrees anteflexion) 30 minutes after insertion of the block and at 24, 48 and 72 hours after surgery No severe complications related to analgesia: more specifically, no infection at insertion points of the catheters. 10 catheters were dislodged. No significant respiratory depression due to opioids, no allergic reactions |
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Notes | Length of follow‐up: until discharge from orthopaedic ward Extra information regarding method of randomization and length of follow‐up supplied by trialists |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized by anaesthesiologists called to the emergency room: "Sealed envelopes: information from the authors to previous reviewers" |
Allocation concealment (selection bias) | Low risk | Sealed 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 | 20% rate of catheter dislodgement, resulting in the need for systemic analgesia Unclear whether participants with dislodged catheters were included in pain scores in their treatment group |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced, including similar admission pain scores (2.50 and 2.46 at rest and 4.30 and 4.34 on movement) |