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Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal (GI) tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay (LOS) is an important surrogate measure of quality after colon surgery and the most common reason for prolonged LOS after abdominal surgery is delayed GI recovery (postoperative ileus).
The Food and Drug Administration (FDA) has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower GI recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery (MDCS) care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative LOS was 5.2 days whereas the mean LOS at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the MDCS care process model.
This trial will investigate if the addition of alvimopan to the Intermountain Healthcare MDCS care process can decrease LOS compared with the MDCS care process plus placebo.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Treatment Group, Control Group
American Fork Hospital
Intermountain Health Care, Inc.
Published on BioPortfolio: 2014-08-27T03:12:56-0400
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