Jayr 1998.
Methods | RCT Ethics committee approval and written informed consent obtained from each patient Setting: France Funding: industry |
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Participants | 141 ASA 1 to 3 patients aged 18 to 75 years and weighing 50 to 110 kg undergoing elective open major abdominal (urological, gynaecological or gastrointestinal) | |
Interventions |
Treatment group: TEA (T12‐L1; level according to surgical site) with 0.2% ropivacaine started after surgery and kept for 24 hours (n = 38) Control group: IV PCA with morphine (n = 46) General anaesthesia for all participants |
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Outcomes | Vomiting | |
Notes | A third group with epidural ropivacaine plus IV morphine was not retained Study authors contacted for additional information; referred us to AstraZeneca, which did not reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation code envelopes" |
Allocation concealment (selection bias) | Low risk | Envelopes opened just before preparation for anaesthesia |
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 | 11 losses to follow‐up |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | More women in the PCA group Not in intention‐to‐treat |