Paulsen 2001.
Methods | RCT Approved by the Institutional Review Board and informed consent obtained Setting: United States of America Funding: unspecified |
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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 |
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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) |
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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 |