Valentin 1986.
Methods | RCT "It was decided not to obtain informed consent from the patients as to participation in the study because a large proportion of patients with hip fractures are old, and mentally unable to reach a logical decision." "Human research committees were not established in Denmark at the start of this investigation" |
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Participants | Orthopaedic hospital in Hellerup, Denmark
662 patients (578 analysed) with a proximal femoral fracture
Mean age 79 years (range 50 ‐ 100)
Male: 20% internal fixation (63%) or hemiarthroplasty (37%) (Moore) Number lost to follow‐up: 2 (0.3%), 84 patients excluded patients wow‐dose heparin treatment were excluded |
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Interventions | No premedication was given to poor‐risk patients; in the others, premedication consisted of pethidine 25‐75 mg, often supplemented with promethazine 12.5‐25 mg, both administered IM, approximately 30 min before the induction of anaesthesia Treatment group: Spinal anaesthesia with 3‐4 mL isobaric bupivacaine injected in the lateral decubitus position. it is unclear whether the fractured side was up or down. Patients were left in that position for 5‐15 minutes until a sensory level to the lower thoracic segments was achieved. Patients were sedated with fentanyl 0.05‐0.1 mg IV and midazolam and some received supplemental oxygen. (n = 281) Control group: General anaesthesia with enflurane and nitrous oxide/oxygen with or without thiopentone at induction or neurolept anaesthesia with droperidol, fentanyl and nitrous oxide/oxygen. All patients having neurolept anaesthesia, and the majority of the patients receiving enflurane received gallamine to provide neuromuscular blockade during the surgical procedure. (n = 297) |
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Outcomes | Mortality at 1 month, 3, 6 and 12 months (read from graphs) | |
Notes | Length of follow‐up: 24 months Mobilization on postoperative day 2 or 3 Antiembolic stockings were provided, but anticoagulant therapy was not given routinely |
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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 | High risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 84 patients excluded from the analysis. Their allocation is not mentioned |
Selective reporting (reporting bias) | Low risk | Not in intention‐to‐treat: "Of the 662 patients admitted to the study, 84 were later excluded by the authors for the reasons listed in table II, leaving data from 578 patients for consideration" |
Other bias | High risk | "the two anaesthetic groups were comparable with respect to age, sex, type of fracture and surgical procedure. Classification according to the ASA criteria was applied to 508 patients: there were more patients in ASA group III in the general anaesthesia group, and more of group IV in the spinal anaesthesia group (P value < 0.02) (table IV). Not in intention‐to‐treat: "Of the 662 patients admitted to the study, 84 were later excluded by the authors for the reasons listed in table II, leaving data from 578 patients for consideration" |