Juelsgaard 1998.
Methods | RCT Approved by the Ethics Committee |
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Participants | Orthopaedic hospital in Aarhus, Denmark 29 followed‐up out of 54 patients with proximal femoral fracture and known coronary artery disease. Patients with a recent (< 6 months) myocardial infarction excluded For 29 patients included in this review: Age: mean 80.9 years (range 65‐99) Male: 13% Number lost to follow‐up: 0, but 11 excluded from original trial population | |
Interventions |
Treatment groups: Single shot (n = 15) with 2.5 mL of 0.5% bupivacaine or incremental doses (0.5 mL every 15 minutes) (n = 14) of the same drug. Considered as two subgroups of the same study
Control group: General anaesthesia with fentanyl 1‐2 mcg/kg, 1‐4 mg/kg thiopentone, 0.5 mg/kg atracurium, nitrous oxide and oxygen and enflurane (n = 14). This group was split in half to be compared with each treatment group separately All patients were premedicated with pethidine 1 mg/kg and received supplemental oxygen for 12 hours after the surgery |
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Outcomes | Mortality at 1 month Operative hypotension (number of patients with 33% reduction in systolic arterial blood pressure from baseline) Myocardial infarction (World Health Organization criteria) | |
Notes | Presenc/absence of thromboprophylaxis not mentioned Length of follow‐up: 1 month |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The investigator was blinded to the treatment group" (ischemias) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | No failed spinal mentioned |
Other bias | Low risk | Groups well balanced |