Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

Summary

This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing narcotic usage or otherwise disrupting the recovery course of patients. Using a double-blind randomized design, either subcutaneous MNTX (0.15 mg/kg rounded to 8 mg or 12 mg) or placebo will be administered starting before surgery and then daily for three days. Information will be collected from medical records in IHIS up to 30 days prior to surgery and then for up to 30 days after surgery.

Timeline

Start

2019-02-21

Primary completion

2021-04-04

Completion

2021-05-12

Publications

• Gifford CS, McGahan BG, Miracle SD, Minnema AJ, Murphy CV, Vazquez DE, Weaver TE, Farhadi HF. Design and feasibility of a double-blind, randomized trial of peri-operative methylnaltrexone for postoperative ileus prevention after adult spinal arthrodesis. Contemp Clin Trials. 2022 Jan;112:106623. doi: 10.1016/j.cct.2021.106623. Epub 2021 Nov 17.

Drugs

Indications