Overview

This trial is active, not recruiting.

Conditions ileus, spinal fusion
Treatments alvimopan, placebo
Sponsor Washington University School of Medicine
Collaborator Orthopedic Research and Education Foundation
Start date August 2014
End date March 2017
Trial size 30 participants
Trial identifier NCT02218190, 201401126

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.
alvimopan Entereg
(Placebo Comparator)
Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven
placebo Sugar Pill

Primary Outcomes

Measure
Recovery of Bowel Function
time frame: 14 days or until hospital discharge whichever occurs first
Length of hospital stay
time frame: 14 days or until hospital discharge whichever occurs first

Secondary Outcomes

Measure
Pain control
time frame: 14 days or until hospital discharge, whichever occurs first
Complications and Adverse event
time frame: 14 days or until hospital discharge, which ever occurs first

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
Principal investigator Michael P Kelly, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.