Trial of Alvimopan in Major Spine Surgery

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Alvimopan

Criteria

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)