Cuschieri 1985.
Methods | RCT Informed consent not mentioned Setting: United Kingdom Funding: charity |
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Participants | 75 patients undergoing open cholecystectomy | |
Interventions |
Treatment group: low thoracic epidural analgesia (catheters inserted after induction and loaded with an age‐related dose of bupivacaine 0.5%) followed by intermittent boluses of 0.5% bupivacaine for 12 hours followed by intramuscular morphine on request (n = 25) Control group: intermittent intramuscular on request (n = 25) or continuous intravenous morphine for 60 hours (n = 25) General anaesthesia for all participants |
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Outcomes | Pain: Participants receiving epidural bupivacaine for 12 hours had better analgesia than those receiving morphine (P value < 0.001) | |
Notes | No serious complications occurred in the epidural group Data not extractable. Study authors contacted on 18 July 2014, but did not reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized", 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, "assessed daily during the postoperative period by a single observer" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up. 4 failed attempts at catheter insertion kept as intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced |