Casati 2003.
| Methods | RCT Approval was obtained from our Institutional Ethics Committee and written informed consent from each participant |
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| Participants | Orthopaedic hospital in Milan, Italy 30 patients of ASA grade II or III undergoing hemiarthroplasty for a proximal femoral fracture Mean age 84 years (range 67‐94) Male: 7% Number lost to follow‐up: 0 | |
| Interventions |
Treatment group: Spinal anaesthesia at L3‐4 with 7.5 mg of hyperbaric bupivacaine injected in lateral decubitus with the patient maintained in this position for 15 minutes (n = 15)
Control group: General anaesthesia with sevoflurane inhalation and laryngeal mask airway. No neuromuscular blocking agent (n = 15) All patients received a standardized protocol for preoperative fluid resuscitation, including blood The day before surgery, all patients had a standard preoperative evaluation, including chest radiography, electrocardiography and routine laboratory tests. Preoperative analgesics consisted of IV ketorolac (30 mg every 8 h). Preoperative fluid resuscitation including transfusion if required to maintain haemoglobin concentration 9 G/L. Postoperative analgesia with tramadol and ketorolac Length of follow‐up: 7 days & hospital discharge |
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| Outcomes | Operative blood loss (taken as P value) Operative hypotension (20% decrease, period undefined). Numbers taken are those requiring a bolus of fluid Acute confusional state within 7 (defined as maximal number of patients with a decrease of 2 points or more on the Mini mental test and this occurred at 24 hours while patients were tested at 24 hours and 7 days) | |
| Notes | Absence/presence of thromboprophylaxis unspecified | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly allocated". Probably adequate considering the use of sealed envelopes although not clearly mentioned |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| 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 | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | No failed spinal mentioned |
| Other bias | Low risk | Groups well balanced |