Moiniche 1993.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Denmark Funding: industry |
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Participants | 31 ASA 1 to 2 patients scheduled for elective cholecystectomy performed through a mini‐laparotomy | |
Interventions |
Treatment group: TEA (T7‐T8) with bupivacaine and morphine intraoperatively and for 38 hours after surgery (n =15) Control group: from 2 to 24 hours postoperatively morphine 0.125 mg/kg IM was administered every 6 hours, and from 24 to 48 hours postoperatively every 8 hours (n = 16) |
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Outcomes | Pain scores at rest at 24 and 48 hours (6‐point scale) Pain scores on movement at 24 and 48 hours (6‐point scale) |
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Notes | In all participants, subcutaneous infiltration of the surgical field with plain bupivacaine 0.25% 15 mL was performed immediately before surgical incision | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised", 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 | One of these participants was excluded because of preoperatively observed orthostatic hypotension (i.e. fall in systolic BP > 20 mm Hg (2.8 kPa), in association with symptoms of dizziness); no other loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat: 1 participant was excluded because of preoperatively observed orthostatic hypotension (i.e. fall in systolic BP > 20 mm Hg (2.8 kPa), in association with symptoms of dizziness) |