Calderon 2004.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Spain Funding: unspecified |
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Participants | 30 ASA 2 to 3 patients aged 30 to 75 years, scheduled for abdominal surgery (pancreatico‐duodenectomy or hemicolectomy) Exclusion criteria were cardiovascular disease or disease of the central nervous system, allergy to opioids or non‐steroidal anti‐inflammatory drugs, long‐term use of opioids or psychotropic drugs, history of addiction to drugs or alcohol abuse and contraindications to epidural analgesia |
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Interventions |
Treatment group: lumbar epidural analgesia (L1‐L2 inserted before surgery), bupivacaine 0.25% 15 mL and fentanyl 1 mcg/kg 40 minutes after surgery followed by 1.5 mL/h of bupivacaine 0.25% and fentanyl 1 mcg/h for 24 hours (n = 15) Control group: morphine 0.15 mg/kg and ketorolac 30 mg IV followed by an infusion of tramadol 300 mg/24 h and ketorolac 90 mg/24 h plus morphine as rescue (n = 15) General anaesthesia with propofol, remifentanil, sevoflurane and rocuronium. Prophylaxis with ondansetron |
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Outcomes | Pain scores (0 to 3) at 6 hours after surgery Vomiting (first 24 hours) |
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Notes | Study authors contacted on 25 June 2015, sent additional data on 13 July 2015 | |
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 |