Trial of Alvimopan in Major Spine Surgery

University of Virginia49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Constipation

Interventions

AlvimopanDRUG

Alviimopan 12 mg twice daily up to 15 doses

PlaceboDRUG

Placebo twice daily up to 15 doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Time to First Bowel Movement

time to first bowel movement after surgery

Time frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement

Secondary Outcomes

Time to Resumption of PO Intake

time to resumption oral intake after surgery

Time frame: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Data from ClinicalTrials.gov

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