Rockemann 1997.
Methods | RCT Approved by the ethics committee Setting: Germany Funding: unspecified |
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Participants | 62 patients undergoing abdominal surgery (gastrointestinal mainly) Exclusion criteria were allergy to 1 of the substances used, age > 65 years, long‐term opioid or corticosteroid use, coagulation disorder and systemic infection |
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Interventions |
Treatment group: thoracic epidural analgesia (T7‐T8 to T10‐T11, catheter introduced 5 to 7 cm passed the needle tip, median approach) with bupivacaine 0.25% and sufentanil 2 mcg/mL (0.05 mL/kg; lockout time 10 minutes) (n = 31) Control group: IV PCA with morphine 2 mg, lockout time 10 minutes (n = 31) General anaesthesia with propofol, sufentanil, nitrous oxide, enflurane and pancuronium. To increase intestinal motility, participants received metoclopramide 10 mg 3 times daily from postoperative day 1, and prostigmine 1 mg as a short infusion from postoperative day 3. Duration of pain treatment was 101 ± 3 hours |
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Outcomes | Time to first faeces Pain scores (0 to 10) at rest and on coughing (taken as on movement) at 24, 48 and 72 hours after surgery Length of hospital stay Costs |
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Notes | Addiitonal data provided by study authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomization table" |
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 |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced |