Clinical trial NCT02218190: Alvimopan and Ileus in PSF
Official title: A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Spinal Fusion
Keywords: Alvimopan
Ileus
Posterior spinal fusion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
name: Barnes-Jewish Hospital
First posted: 2014-08-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Recovery of Bowel Function
timeFrame: 14 days or until hospital discharge whichever occurs first
measure: Length of Hospital Stay
timeFrame: 14 days or until hospital discharge whichever occurs first
Secondary outcomes:
measure: Complications and Adverse Event
timeFrame: 14 days or until hospital discharge, which ever occurs first
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital / Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine
name: Michael P Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
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