Hjortsø 1985b.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Denmark Funding: industry |
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Participants | 20 patients undergoing elective major abdominal surgery (bowel or gastric resection and 1 cholecystectomy) | |
Interventions |
Treatment group: epidural anaesthesia with 1.5% etidocaine during surgery and bupivacaine 0.5% bolus for 24 hours after surgery. In addition, extradural morphine 4 mg was administered every 12 hours from 3 to 72 hours after skin incision (n = 10) Control group: systemic morphine (n = 10) |
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Outcomes | VAS at 24, 48 and 72 hours (average pain experienced during the preceding 24 hours) taken as at rest | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized into two groups", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or epidural failure mentioned |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced |