Alvimopan and Ileus in PSF

Not Applicable

Completed

• Conditions: Ileus; Spinal Fusion
• Interventions: Drug: Alvimopan; Drug: Placebo

• Registration Number: NCT02218190
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2016-01
• Study Completion: 2019-01
• Results First Submitted: 2019-04-01
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Results First Posted: 2019-05-17
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alvimopan	Alvimopan	Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.
Placebo - Sugar Pill	Placebo	Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven

Primary Outcome Measures

Name	Time	Method
Recovery of Bowel Function	14 days or until hospital discharge whichever occurs first	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.
Length of Hospital Stay	14 days or until hospital discharge whichever occurs first	To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.

Secondary Outcome Measures

Name	Time	Method
Complications and Adverse Event	14 days or until hospital discharge, which ever occurs first	Number of patients with complication/adverse event.

Trial Locations

Locations (1)

Barnes Jewish Hospital / Washington University in St. Louis School of Medicine; 🇺🇸 Saint Louis, Missouri, United States