Brichant 1995.
Methods | RCT Approved by the Ethics Committee and informed consent obtained from each patient |
|
Participants | Orthopaedic hospital in Brussels, Belgium
106 patients with proximal femoral fracture
Age: not stated
Male: percentage not stated
Number lost to follow‐up: not stated Operated between 10 and 72 hours after admission Length of follow‐up: 10 days |
|
Interventions | Treatment group: Neuraxial block (spinal or epidural) anaesthesia with bupivacaine (n = 54 randomized; 46 analysed) Control group: General anaesthesia administered according to 'local practice' (n = 52 randomized; 42 analysed) | |
Outcomes | Deep vein thrombosis (venography) Pulmonary embolism (confirmed with angiography or lung ventilation/perfusion scan) | |
Notes | Conference abstract only All patients had subcutaneous nadroparin for DVT prophylaxis for 10 days and contralateral stocking | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated", 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 | Independent panel of experts unaware of the treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | > 20% excluded from analysis |
Selective reporting (reporting bias) | Low risk | No failed spinal mentioned |
Other bias | Low risk | Groups said to be well balanced |