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

Levy 2011.

Methods RCT
Approved by the ethics committee and consent obtained
Registration number: NCT 18926278
Setting: United Kingdom
Funding: departmental
Participants Patients with colorectal disease (benign or malignant) who required a laparoscopic large bowel resection that did not involve a stoma or perineal dissection were considered for the trial
Interventions Treatment group: TEA (T9‐T12) with bupivacaine 0.15% and fentanyl 2 mcg/mL for 48 hours (n = 30)
Control group: IV PCA with morphine (n = 30)
General anaesthesia for all participants
Outcomes Time to first faeces
VAS scores on movement/coughing (whichever worst), evening (taken as 6 to 8 hours), 24 hours
Leak
Hospital LOS (from the start of surgery)
Notes Study also includes a group with spinal analgesia, not retained in our analysis
Study authors contacted for additional information on 21 July 2014, but did not reply
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization code was created by an independent company, which used a computer randomization programme to generate the sequence, then placed the appropriate analgesic regimen in sequentially numbered opaque envelopes
Allocation concealment (selection bias) Low risk The randomization code, which was kept in an opaque envelope in an off‐site building, was opened after consent was obtained
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 99 included and 91 completed the trial
Selective reporting (reporting bias) Low risk All results reported
Other bias Unclear risk Groups well balanced except higher body weight for the opioids group
Not in intention‐to‐treat