Expired Study
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Saint Louis, Missouri 63108


Purpose:

The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.


Study summary:

Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control. We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.


Criteria:

Inclusion Criteria: - adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis Exclusion Criteria: - pregnant women - ischemic heart disease - chronic liver or renal disease - prior bowel resection - presence of colostomy or ileostomy - gastroparesis - complete bowel obstruction - inflammatory bowel disease (ulcerative colitis or Crohn's disease).


NCT ID:

NCT02218190


Primary Contact:

Principal Investigator
Michael P Kelly, MD
Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63108
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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