Alvimopan and Ileus in PSF
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | August 2014 |
| End Date: | January 2019 |
A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
The purpose of the study is to determine with Alvimopan reduces the incidence of post
operative ileus in patients who undergo posterior spinal fusion.
operative ileus in patients who undergo posterior spinal fusion.
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.
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.
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).
We found this trial at
1
site
4940 Forest Park Avenue
Saint Louis, Missouri 63108
Saint Louis, Missouri 63108
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