Alvimopan and Ileus in PSF

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

Detailed Description
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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.

Official Title
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A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion

Conditions
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Ileus, Spinal Fusion

Intervention / Treatment
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* Drug: Alvimopan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alvimopan<br>Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. | Drug: Alvimopan<br> <br> * Other names: Entereg;|
| Placebo Comparator: Placebo - Sugar Pill<br>Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven | Drug: Placebo<br> <br> * Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of Bowel Function | To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement. | 14 days or until hospital discharge whichever occurs first | 
| Length of Hospital Stay | To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF. | 14 days or until hospital discharge whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications and Adverse Event | Number of patients with complication/adverse event. | 14 days or until hospital discharge, which ever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alvimopan, Ileus, Posterior spinal fusion