Trial of Alvimopan in Major Spine Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT02789111

Run by

University of Virginia

People needed

49

Starts

2016-06-01

Expected to finish

2018-12-01

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Major spine surgery scheduled as part of clinical care
• 18-80 years

You may not qualify if…

• 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)

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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