Carli 1997.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Canada Funding: unspecified |
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Participants | 12 patients undergoing elective gastrointestinal surgery for resection of non‐metastatic adenocarcinoma of the rectosigmoid colon Exclusion criteria were anaemia, diabetes mellitus, morbid obesity and severe cardiovascular disease |
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Interventions |
Treatment group: thoracic (T8) epidural analgesia with 10 to 15 mL of 0.75% bupivacaine for a sensory block from T3 to S5 followed by 5 mL every 90 minutes during surgery and an infusion of 0.25% bupivacaine at 8 to 12 mL/h for 48 hours. Intramuscular papaveratum as required (n = 6) Control group: subcutaneous infusion of papaveratum at 3 to 8 mg/h (n = 6) General anaesthesia for all participants |
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Outcomes | Pain: Postoperative pain scores in the epidural group ranged from 0.6 to 1.6 at rest and from 2.3 to 4.1 on coughing. Pain scores in the control group ranged from 0.8 to 2.1 at rest and from 2.4 to 6.3 on coughing. No significant difference in pain scores at rest was observed between the 2 groups. In contrast, pain scores on coughing were lower in the epidural group (P value = 0.021) | |
Notes | Data not extractable; study authors contacted on 4 May 2015; informed us that data are no longer available Participants in the epidural group could not move on first postoperative day owing to a motor block |
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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 |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced |