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. 2016 Jul 15;2016(7):CD001893. doi: 10.1002/14651858.CD001893.pub2

Schulze 1988.

Methods RCT
Approved by the ethics committee and informed consent obtained
Setting: Denmark
Funding: industry (in part)
Participants 24 patients undergoing elective open cholecystectomy
Exclusion criteria were signs of cardiopulmonary, endocrinological, renal hepatic or immunological disease or infection within 1 week
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
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