Trial of Alvimopan in Major Spine Surgery

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: Placebo
Drug: Alvimopan

Registration Number: NCT02789111

Lead Sponsor: University of Virginia

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Alvimopan	Alvimopan	12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.

Primary Outcome Measures

Name	Time	Method
Time to First Bowel Movement	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 Outcome Measures

Name	Time	Method
Time to Resumption of PO Intake	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