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. 2016 Jul 15;2016(7):CD001893. doi: 10.1002/14651858.CD001893.pub2

Moiniche 1993.

Methods RCT
Approved by the ethics committee and informed consent obtained
Setting: Denmark
Funding: industry
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)
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)
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)