Berggren 1987.
| Methods | RCT. The study was approved by the Ethics Committee of the University of Umeå. Informed consent | |
| Participants | Orthopaedic hospital in Umea, Sweden
57 patients with a femoral neck fracture
Mean age 77/78 years (range 65‐92 years)
Male: 19%
Number lost to follow‐up: 4 (7%) Length of follow‐up: 12 months Only fully lucid participants were included in the study For fixation, either hookpins or von Bahr screws were used. In two patients with fractures close to the trochanteric area, fixation was achieved with a sliding screw and a plate Forty‐two of the patients (74%) were operated on within 36 hr of sustaining their fractures, the remaining patients were operated on within 72 hr |
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| Interventions | Both groups premedicated with pethidine 25‐50 mg Treatment group: Neuraxial block (epidural anaesthesia) with 2% prilocaine in the epidural space, mean volume used 12.5 mL. The catheter was removed in the postanaesthesia care unit (n = 28) Control group: General anaesthesia with thiopentone 3‐4 mg/kg, atropine 0.25‐0.5 mg IV, succinylcholine ventilated with nitrous oxide and oxygen and halothane and succinylcholine infusion (n = 29) | |
| Outcomes | Mortality at 30 days and 3 months
Acute confusional state within 7 days (modified Organic Brain Syndrome Scale) (performed by 2 investigators with a 90% interrater reliability) Cerebrovascular accident Pneumonia (requiring treatment) Congestive heart failure (requiring treatment) Pulmonary embolism (requiring treatment) Operative hypotension (> 30% not responsive to treatment) Length of surgery Urine retention |
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| Notes | 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. Thromboprophylaxis with dextran plus mobilization on first postoperative day when possible. No mention on the type of drugs used for postoperative analgesia | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized", no detail |
| 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 | Outcome assessors were blinded for the postoperative acute confusional state but presence/absence of blinding not mentioned for all other outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Four participants lost to follow‐up 4 died by 1 year, 1 in the epidural group on 1st postoperative day, the other 3 (group not given) by 5 months. Patients were interviewed at 6 and 12 months regarding living conditions and walking ability ‐ data not presented |
| Selective reporting (reporting bias) | Unclear risk | Some results (see above) not provided |
| Other bias | Low risk | The two groups were comparable with regard to age, sex, pre‐existing diseases, and preoperative medications (Table 2), except for drugs with anticholinergic effects, which were used significantly more frequently in the epidural group. We identified no other serious risk of bias |