Couderc 1977.
Methods | RCT | |
Participants | Orthopaedic hospital in Paris, France
100 patients with a proximal femoral fracture (nail and plate n = 56; hemiarthroplasty n = 44)
Mean age 86 years. (Inclusion criterion: 80+ years; range not stated)
Male: 14%
Number lost to follow‐up: not stated Operated within 24 hours after admission |
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Interventions |
Treatment group: Five to seven hundreds mL of fluid (LR or colloid). Neuraxial block (epidural anaesthesia) in lateral decubitus consisting of single shot or continuous infusion of 0.5% bupivacaine and adrenaline with or without lidocaine (n = 50)
Control group: General anaesthesia with thiopentone, pancuronium or succinylcholine, dextromoramide or methoxyflurane, nitrous oxide/oxygen (n = 50) Premedicated with hydroxyzine and atropine |
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Outcomes | Mortality at 3 months (cumulative) Operative hypotension ( ≥ 40 mm HG; number of patients at induction of anaesthesia) Myocardial infarction (serial preprogrammed EKGs and enzymes) | |
Notes | In French Length of follow‐up: 3 months Complete data for fatal myocardial infarction, congestive heart failure and pulmonary embolism not provided Early mobilization and anti‐vitamin K from day 3 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized study: by 'drawing of lots' |
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 | High risk | EKG interpreted by a blinded cardiologist. Not blinded for the other outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | No failed epidural reported |
Other bias | Low risk | Groups well balanced |