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

Paulsen 2001.

Methods RCT
Approved by the Institutional Review Board and informed consent obtained
Setting: United States of America
Funding: unspecified
Participants 49 patients (men and women) aged 18 years or older who were scheduled to undergo elective small bowel or colon resection with a primary anastomosis
Interventions Treatment group: TEA (T10‐T12) with bupivacaine 0.1% and fentanyl 5 mcg/mL for 3.7 days as a mean (n = 23)
Control group: IV PCA with morphine or meperidine (n = 21)
General anaesthesia for all participants
Outcomes Time to first flatus
Time to first faeces
VAS scores (taken as at rest) at 24, 48 and 72 hours
Leak
Hospital length of stay
Cost (analgesia plus room)
Notes 4% of participants (n = 1) in the EPI arm required removal of bupivacaine from the epidural solution secondary to lower extremity paraesthesia
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomized", no details
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes High risk "the study was not blinded"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "the study was not blinded"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 49 participants were enrolled into the study. 5 of these participants were removed after enrolment (1 (EPI) and required mechanical ventilation for 24 hours after surgery, 3 (PCA) were not able to provide pain scores and 1 (PCA) was found to have extensive bowel necrosis at laparotomy and did not undergo resection
Selective reporting (reporting bias) Low risk All results reported
Other bias Unclear risk More diabetic participants in the opioids group. The type of surgical procedure performed was similar between the 2 groups
Not in intention‐to‐treat