A Double-blind, Randomized, Placebo-controlled Trial of Naloxegol for Prevention of Post-operative Constipation in Spinal Surgery Patients

NCT02946580 Phase 4 TERMINATED Results posted

Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	TERMINATED
Enrolment	53
Start date	2017-01
Completion	2018-02

Conditions

• Constipation

Interventions

• MOVANTIK™ (naloxegol)
• Sugar Pill

Primary outcomes

• Time to First Post-operative Spontaneous Bowel Movement — through study completion, an average of 6 days
  The primary endpoint of the study was time to first post-operative bowel movement, as defined by the first spontaneous bowel movement reported by nursing staff after transfer from the surgical suite to the inpatient floor. A bowel movement was defined as the spontaneous passage of one tablespoon or more of liquid or solid stool (excluding flatus), which could be measured and verified by nursing staff. Time was measured in hours post-operatively with the starting time point marked at the end of the surgical procedure.

Countries

United States