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The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus (FusionIleus)

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ClinicalTrials.gov Identifier: NCT03176316
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Russel Nockels, 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.

Condition or disease Intervention/treatment Phase
Ileus Fusion of Spine Drug: Naloxone Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naloxone
1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours
Drug: Naloxone

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





Primary Outcome Measures :
  1. Time to first bowel movement [ Time Frame: 1 week ]
    We will be monitoring the patients bowel movements and recording the time to the first bowel movement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176316


Contacts
Contact: Kevin Swong, MD 8158306957 knswong@gmail.com
Contact: Stephen Johans, MD 3147533049 johanssj@gmail.com

Locations
United States, Illinois
LUMC Recruiting
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Russell Nockels, MD Loyola University

Publications of Results:
Other Publications:
Responsible Party: Russel Nockels, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03176316     History of Changes
Other Study ID Numbers: 209439
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Russel Nockels, Loyola University:
ileus
fusion of spine

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents