Davis 1981.
| Methods | Randomized trial: method not stated | |
| Participants | Orthopaedic hospital Christchurch, New Zealand
132 patients with a proximal femoral fracture (intertrochanteric, basicapital or subcapital) and coming within 72 hours of the injury
Mean age 81/78 years (Inclusion criterion: 50+, range not given)
Male: 15%
Number lost to follow‐up: 0 Patients < 50 years of age, requiring arthroplasty or with cardiac heart failure were excluded |
|
| Interventions |
Treatment group: Spinal anaesthesia in lateral decubitus on the fractured side using hyperbaric tetracaine 0.5% in 51 patients and hyperbaric 0.5% cinchocaine in 13 patients. Patients were retained in this position for 10 minutes. Ketamine also used for sedation in 8 patients (positioning for the spinal). Sedation also provided with diazepam (mean dose 9 mg). Supplemental oxygen or a mixture of nitrous oxide and oxygen during the surgery (n = 64)
Control group: General anaesthesia with diazepam (2.5‐30 mg) mean dose 9.5 mg, fentanyl 1‐3 mcg/kg, nitrous oxide and oxygen, IPPV, pancuronium (mean dose 6 mg) (n = 68). Infusion of 200‐400 mL of fluids before induction for all patients Length of follow‐up : 1 month |
|
| Outcomes | Mortality ‐ at 1 month
Operative hypotension Number of patients transfused Pneumonia Cerebrovascular accident Congestive heart failure Acute kidney injury Deep vein thrombosis (fibrinogen) (available in 76 patients only) |
|
| Notes | Presence/absence of thromboprophylaxis not mentioned | |
| 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 | High risk | Incomplete data for deep venous thrombosis (76/132) |
| Selective reporting (reporting bias) | Low risk | Eight failed spinal |
| Other bias | Low risk | Groups well balanced. Intention‐to‐treat analysis |