The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus (FusionIleus)
Primary Purpose
Ileus, Fusion of Spine
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naloxone
Sponsored by
About this trial
This is an interventional prevention trial for Ileus focused on measuring ileus, fusion of spine
Eligibility 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
Sites / Locations
- LUMCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Naloxone
Arm Description
1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours
Outcomes
Primary Outcome Measures
Time to first bowel movement
We will be monitoring the patients bowel movements and recording the time to the first bowel movement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03176316
Brief Title
The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Acronym
FusionIleus
Official Title
The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Fusion of Spine
Keywords
ileus, fusion of spine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Naloxone
Arm Type
Experimental
Arm Description
1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours
Intervention Type
Drug
Intervention Name(s)
Naloxone
Intervention Description
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 Measure Information:
Title
Time to first bowel movement
Description
We will be monitoring the patients bowel movements and recording the time to the first bowel movement
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Swong, MD
Phone
8158306957
Email
knswong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Johans, MD
Phone
3147533049
Email
johanssj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Nockels, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUMC
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24184650
Citation
Fineberg SJ, Nandyala SV, Kurd MF, Marquez-Lara A, Noureldin M, Sankaranarayanan S, Patel AA, Oglesby M, Singh K. Incidence and risk factors for postoperative ileus following anterior, posterior, and circumferential lumbar fusion. Spine J. 2014 Aug 1;14(8):1680-5. doi: 10.1016/j.spinee.2013.10.015. Epub 2013 Oct 31.
Results Reference
background
PubMed Identifier
19250137
Citation
Arpino PA, Thompson BT. Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. J Clin Pharm Ther. 2009 Apr;34(2):171-5. doi: 10.1111/j.1365-2710.2008.00982.x.
Results Reference
background
PubMed Identifier
18762438
Citation
Meissner W, Leyendecker P, Mueller-Lissner S, Nadstawek J, Hopp M, Ruckes C, Wirz S, Fleischer W, Reimer K. A randomised controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. Eur J Pain. 2009 Jan;13(1):56-64. doi: 10.1016/j.ejpain.2008.06.012. Epub 2008 Aug 31.
Results Reference
background
PubMed Identifier
10601678
Citation
Meissner W, Schmidt U, Hartmann M, Kath R, Reinhart K. Oral naloxone reverses opioid-associated constipation. Pain. 2000 Jan;84(1):105-109. doi: 10.1016/S0304-3959(99)00185-2.
Results Reference
background
PubMed Identifier
8800821
Citation
Sykes NP. An investigation of the ability of oral naloxone to correct opioid-related constipation in patients with advanced cancer. Palliat Med. 1996 Apr;10(2):135-44. doi: 10.1177/026921639601000208.
Results Reference
background
PubMed Identifier
11212050
Citation
Lee J, Shim JY, Choi JH, Kim ES, Kwon OK, Moon DE, Choi JH, Bishop MJ. Epidural naloxone reduces intestinal hypomotility but not analgesia of epidural morphine. Can J Anaesth. 2001 Jan;48(1):54-8. doi: 10.1007/BF03019815.
Results Reference
background
PubMed Identifier
18828197
Citation
McNicol E, Boyce DB, Schumann R, Carr D. Efficacy and safety of mu-opioid antagonists in the treatment of opioid-induced bowel dysfunction: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2008 Sep;9(6):634-59. doi: 10.1111/j.1526-4637.2007.00335.x.
Results Reference
result
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The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
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