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Completed

NCT Number: NCT02789111

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Alvimopan

Drug

Alviimopan 12 mg twice daily up to 15 doses

Other names: Entereg

Placebo

Drug

Placebo twice daily up to 15 doses

Primary outcomes

  1. Time to First Bowel Movement

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

    time to first bowel movement after surgery

Secondary outcomes

  1. Time to Resumption of PO Intake

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

    time to resumption oral intake after surgery

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2016
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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