Trial of Alvimopan in Major Spine Surgery

Therapuetic Areas:Gastroenterology
Age Range:18 - 80
Start Date:June 1, 2016
End Date:December 1, 2018
Contact:Marcia E Birk, RN

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Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery

The Investigator has chosen to study the reconstructive spinal surgery patient population
because it is believed that the use of alvimopan in these patients at the University of
Virginia will give the scientific community significant insight into the broader
applicability of this drug into other surgical populations, the impact of this drug on the
perception of pain (as opposed to simply the consumption of opioids), and its impact on total
hospital charges, resource utilization, and functional outcomes.

Pain control following major spine surgery is difficult to achieve. Opiates are often
necessary in high doses, and may be associated with significant side effects. Such side
effects may include urinary retention, altered mental status, depressed respiratory drive,
and constipation, and may lead to reduced nutritional intake in the postoperative period.
Importantly, post-operative nutrition may impact the incidence of complications following
spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the
gastrointestinal complications of perioperative systemic opioid administration.

Pain control following major spine surgery is difficult to achieve. Opiates are often
necessary in high doses, and may be associated with significant side effects including
constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is
used to help the bowel recover more quickly in patients who are having bowel surgery, so that
they can eat solid foods and have regular bowel movements. Alvimopan is in a class of
medications called peripherally acting mu-opioid receptor antagonists. It works by protecting
the bowel from the constipation effects of opioid (narcotic) medications that are used to
treat pain after surgery.

The purpose of this study is to determine if the use of alvimopan in major spine surgery
reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive
spinal surgery patients, researchers hope to give the scientific community insight into the
broader use of this drug in other surgical populations, as well as gathering information on
the impact of hospital charges and overall post-operative patient satisfaction.

Inclusion Criteria:

- Major spine surgery scheduled as part of clinical care

- 18-80 years

Exclusion Criteria:

- More than three doses of any opioid within one week of surgery

- Pregnancy

- Prisoners

- Unable to provide consent

- Emergency surgery

- Chronic kidney disease stage 5 (GFR < 15 ml/min)

- Severe hepatic impairment

- Recent myocardial infarction (within the last 3 months)
We found this trial at
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Bhiken Naik, MBBCh
Phone: 434-924-2283
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Charlottesville, VA
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