Wiedemann 1991.
Methods | RCT Informed consent obtained Setting: Germany Funding: unspecified |
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Participants | 28 male patients undergoing upper abdominal surgery (mainly proximal vagotomy for duodenal ulcer) | |
Interventions |
Treatment group: thoracic epidural (T7‐T9, inserted the day before surgery through a paramedian approach) with 12 to 14 mL of 0.5% bupivacaine followed by 12 to 14 mL/h of bupivacaine (0.25% for 12 to 18 hours, then 0.125%) started before induction and continued for 48 hours (targeted sensory level T4) (n = 8) Control groups: thoracic epidural morphine 4 to 5 mg 30 minutes before induction and every 12 hours (n = 10) or IM piritramide Neuroleptanaesthesia with etomidate, succinylcholine, fentanyl, droperidol, nitrous oxide and pancuronium |
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Outcomes | Pain scores at rest at 6, 24 and 48 hours (scale 0 to 4) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned", 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 mentioned No failed epidural mentioned but groups unequal (8 vs 10 and 10) |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced |