The purpose of the study is to determine with Alvimopan reduces the incidence of post
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.
- adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis
- pregnant women
- ischemic heart disease
- chronic liver or renal disease
- prior bowel resection
- presence of colostomy or ileostomy
- complete bowel obstruction
- inflammatory bowel disease (ulcerative colitis or Crohn's disease).