Turunen 2009.
Methods | RCT Approved by the ethics committee and written informed consent obtained from each patient Setting: Finland Funding: unspecified |
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Participants | 60 ASA physical status score of 1 to 3 consecutive elective patients with complicated diverticular disease (1 acute episode in patients younger than 50 years, and 2 in older patients, or a preoperative stricture) undergoing laparoscopic sigmoid resection | |
Interventions |
Treatment group: TEA (T10‐T11) with ropivacaine 0.5% during surgery and ropivacaine 0.2% for 48 hours after surgery (n = 29) Control group: IV or IM oxycodone (n = 29) General anaesthesia for all participants. All participants received daily doses of ketoprofen including three 100‐mg doses administered intravenously (IV) or orally, 4 paracetamol 1‐g doses given IV or orally and, if needed, oxycodone 0.05 mg/kg IV or 0.15 mg/kg administered intramuscularly |
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Outcomes | Time to first flatus VAS scores on movement at 24, 48 and 72 hours Leak |
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Notes | Study authors contacted for additional information on 12 July 2014, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization in blocks of 10" |
Allocation concealment (selection bias) | Low risk | "sealed envelopes" |
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 | 1 participant from each group was excluded because of a missing self care questionnaire |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced. "The data were analyzed on an intention‐to‐treat basis, which means that patients with unsuccessful epidural analgesia were counted as epidural analgesia patients" |