The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Conditions
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Ileus, Fusion of Spine

Intervention / Treatment
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* Drug: Naloxone


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Pregnancy, age < 18, nursing, or documented allergy to naloxone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A paired t-test will be used to estimate the mean difference in hours to first feces between the active cohort and historical control cohort. If necessary, a Wilcoxon signed ranks test will be used to compare the two distributions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naloxone<br>1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours | Drug: Naloxone<br>* Blinding/labeling/preparation of agents: No blinding is required in this study. The study drug will be prepared, unit dose labelled, and patient labelled according to institutional protocols. Storage: Secured at room temperature in the central pharmacy then dispensed as a patient specific supply and stored at room temperature the automated dispensing cabinet. No more than a 24 hour supply will be dispensed at any given time. Administration: 1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bowel movement | We will be monitoring the patients bowel movements and recording the time to the first bowel movement | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileus, fusion of spine