Gherghina 2010.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Romania Funding: unspecified |
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Participants | 70 patients older than 70 years of age and undergoing major abdominal surgery (gastrointestinal mainly). Criteria for inclusion of patients in the study were age over 70 years, ASA physical status 1 to 3, major abdominal surgery, normal preoperative neurological status and Abbreviated Mental Test score ≥ 8 | |
Interventions |
Treatment group: TEA/LEA with bupivacaine 0.125% and sufentanil 5 mcg/mL started before surgery and kept for 79 hours (n = 35 randomized; 33 analysed) Control group: IV PCA with morphine (n = 35 randomized; 31 analysed) General anaesthesia with propofol, sufentanil, sevoflurane and atracurium. Rescue analgesia (VAS > 3) with paracetamol (1 G IV) or ketoprofen 100 mg IV |
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Outcomes | Time to return of intestinal transit (taken as time to first flatus) | |
Notes | Study authors contacted on 23 June 2015, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomisation 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 | High risk | Six participants lost to follow‐up: 4 in the epidural group and 2 in the opioid‐based regimen group |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |