de Visme 2000.
Methods | RCT Approved by the Research and Ethics Committees and written informed consent from all patients |
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Participants | Orthopaedic hospital in Brest, France
29 patients with a proximal femoral fracture (69% trochanteric and 31 % femoral neck)
Mean age 85 years (range 68‐97)
Male: 17%
Number lost to follow‐up: none Evidence of cognitive deficit (MMSE lower than 5), contraindication to SA, or peripheral nerve block, resulted in exclusion Length of follow‐up: not stated but probably 5 days |
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Interventions |
Treatment group: Lumber plexus (30 mL Winnie's technique), sacral plexus (10 mL Mansour's technique) with 1.33% lidocaine and adrenaline (1:240,000) and 5 mL 1% lidocaine for the iliac crest block (for lateral cutaneous nerve) (n = 15). Neurostimulation at 0.8 mA accepted Control group: Spinal anaesthesia at L3‐4 with 3 mL 0.5% plain bupivacaine (n = 14) All patients received 250 mcg alfentanil before being turned to the lateral position, with the operated side uppermost The patients were given 5 mL/kg of Hartman solution before the 5 mL/kg/h of the same solution until transferred to the recovery room. Ephedrine for systolic < 90 mmHG or 30% decrease |
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Outcomes | Length of surgery Acute confusional state within 7 days |
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Notes | There were no complications that could be attributed to the techniques In both groups, adequate muscle relaxation was present for all patients to ensure manipulation for positioning of the injured extremity and fracture reduction Presence/absence of thromboprophylaxis not mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients were randomly assigned by the hospital pharmacy just before transfer to the operating area to 2 groups |
Allocation concealment (selection bias) | Low risk | See above |
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 | Patients in the CPNB group required light adjunct of drugs (alfentanil 250 mcg) 3 times for the incision (anaesthesia was judged incomplete) and 1 patient received sedation repeatedly (anaesthesia was judged unsatisfactory). No conversion to GA |
Other bias | Unclear risk | Groups well balanced |