The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Last updated: June 27, 2024
Sponsor: Loyola University
Overall Status: Terminated

Phase

4

Condition

Ileus

Treatment

Naloxone

Clinical Study ID

NCT03176316
209439
  • Ages > 18
  • All Genders

Study Summary

Postoperative ileus and opioid induced constipation are well-known post-operative complications. Previously, research has shown that using peripherally acting opioid antagonists can help alleviate the condition. There has not been a prospective study to investigate whether use of peripherally acting opioid antagonists are effective in preventing post-operative ileus in patients having spinal fusion surgeries.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients will be included if they are having an in-patient spinal fusion procedure,are 18 years or older, post and post-operative pain control plan includes opioidmedications.

Exclusion

Exclusion Criteria:

  • Pregnancy, age < 18, nursing, or documented allergy to naloxone

Study Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: Naloxone
Phase: 4
Study Start date:
September 20, 2017
Estimated Completion Date:
February 20, 2020

Study Description

Post operative ileus is a well-known complication following spinal fusion surgery. There has been some literature to demonstrate the safety and efficacy of oral naloxone to decrease the time to bowel movements after gastrointestinal surgery, to date, there have been no studies within the spine fusion literature to investigate oral naloxone's effects on the time to bowel movements.

The aim of the present study is to use the previously established protocols and doses established in the gastrointestinal literature to see whether oral naloxone can decrease the time to first bowel movements.

Connect with a study center

  • LUMC

    Maywood, Illinois 60153
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.