The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Phase 4

Terminated

• Conditions: Fusion of Spine; Ileus
• Interventions: Drug: Naloxone

• Registration Number: NCT03176316
• Lead Sponsor: Loyola University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-09-20
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Results First Submitted: 2024-04-01
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Results First Posted: 2024-07-01
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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 opioid medications.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naloxone	Naloxone	1 mg/ml oral solution administered enterally every eight hours for 48 hours

Primary Outcome Measures

Name	Time	Method
Time to First Bowel Movement	1 week	We will monitor the patients' bowel movements and record the time to the first bowel movement in hours

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States