Luger 2012.
Methods | RCT Approved by the ethics committee and written informed consents obtained Setting: Austria Funding: departmental resources |
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Participants | Included: 37 very elderly participants (> 80 years) with hip fractures (of whom 3 with dementia had to be excluded) scheduled for surgery under spinal anaesthesia Excluded: score < 18 on the Mini‐Mental State Examination, surgery did not take place within 36 hours, known intolerance or allergies to drugs, planned or required general anaesthesia, refusal of consent, participation in a different study, administration of midazolam as premedication, chronic pain, contraindications and spinal anaesthesia failure, incomplete data records |
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Interventions |
Treatment groups: ultrasound‐guided continuous femoral (3‐in‐1) nerve block with bupivacaine (n = 10) Control group: systemic analgesia with IV/SC piritramide and IV paracetamol (n = 10) |
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Outcomes | Pain scores at rest and on movement at 24 hours after surgery Opioids at 24 hours after surgery Number of participants with postoperative myocardial ischaemia |
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Notes | Study also includes a group with epidural analgesia ‐ not retained in this review | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The patients were randomized according to a computer‐generated randomization list" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
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 | No drop‐out for the 2 included subgroups |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups comparable |