Schulze 1988.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Denmark Funding: industry (in part) |
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Participants | 24 patients undergoing elective open cholecystectomy Exclusion criteria were signs of cardiopulmonary, endocrinological, renal hepatic or immunological disease or infection within 1 week |
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Interventions |
Treatment group: thoracic epidural analgesia with plain bupivacaine 0.5% for 24 hours, then 0.25% for another 24 hours (T4‐L1) and epidural morphine 4 mg every 8 hours thereafter for 96 hours plus systemic indomethacin 100 mg every 8 hours for 96 hours (n = 12) Control group: intermittent nicomorphine (10 to 15 mg) and acetaminophen (1 G) on request (n = 12) General anaesthesia for all participants |
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Outcomes | Pain at rest and on coughing at 6, 24 and 48 hours: "The patients in the opioids group had significantly more pain during the postoperative course (P < 0.001)" | |
Notes | Data not extractable. Study authors contacted on 3 June 2016. Replied that data are no longer available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" |
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 | 3 participants requiring bile duct exploration were excluded |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |