Bigler 1985.
| Methods | Randomized trial: method not stated. Informed consent was obtained from all patients and the protocol was approved by the ethical committee of Copenhagen hospitals | |
| Participants | Place and country of study not stated
40 patients with a proximal femoral fracture operated within 48 hours
Mean age 79 years.
Male: 17.5%
Loss to follow‐up: not known Patients in whom there were contraindications to spinal analgesia, with subtrochanteric fractures, severe dementia, cancer and with psychiatric or disseminated neurological disease were not studied Lateral approach to the hip fixation |
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| Interventions |
Treatment group: Spinal anaesthesia with 3 mL of 0.75% bupivacaine at L3‐4 in the lateral decubitus position on the fractured side (n = 20)
Control group: General anaesthesia using atropine, fentanyl, pancuronium, nitrous oxide/oxygen, diazepam and suxamethonium (n = 20) All were premedicated with intramuscular pethidine 75 mg and normal saline 10 mL/kg was given intravenously before anaesthesia. if systolic arterial blood pressure fall exceeded 30% of the preoperative value, intravenous and intramuscular ephedrine 12.5 and 37.5 mg respectively were given |
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| Outcomes | Length of surgery Number of patients transfused Mortality at 1 month Acute confusional state within 7 days Pneumonia Cerebrovascular accident Congestive cardiac failure Pulmonary embolism |
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| Notes | Length of follow‐up: 3 months. This study was designed to evaluate the difference in postoperative acute confusional state after the surgery. No a priori definition or specification time of evaluation was given for all other types of complications. Attempt to early mobilization only as thromboprophylaxis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly allocated to spinal analgesia or general anaesthesia." 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 | Unclear risk | Assessor blinded to the anaesthetic technique used for mental tests Unspecified for the other outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout or failed block reported |
| Selective reporting (reporting bias) | Low risk | No failed spinal mentioned |
| Other bias | Low risk | The two groups were comparable in relation to age, sex, ASA physical status, preoperative haemoglobin and blood pressure. Preoperative mental scores were slightly (not statistically significantly) lower in the spinal group |