Levy 2011.
Methods | RCT Approved by the ethics committee and consent obtained Registration number: NCT 18926278 Setting: United Kingdom Funding: departmental |
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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 |
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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) |
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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 |
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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 |