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

This study is not yet open for participant recruitment.
Verified May 2017 by Russel Nockels, Loyola University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176316
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Russel Nockels, Loyola University
  Purpose
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 Intervention Phase
Ileus Fusion of Spine Drug: Naloxone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Russel Nockels, Loyola University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 150
Anticipated Study Start Date: August 30, 2017
Estimated Study Completion Date: January 1, 2018
Estimated Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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 Not yet recruiting
Maywood, Illinois, United States, 60153
Contact: Kelly Shaffer         
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Russell Nockels, MD Loyola University
  More Information

Publications:

Responsible Party: Russel Nockels, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03176316     History of Changes
Other Study ID Numbers: 209439
First Submitted: May 31, 2017
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: May 2017
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