The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

NCT03176316 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 209439
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus; Fusion of Spine

Keywords

ileus; fusion of spine

Outcome Measures

Primary Outcomes (1)

• Time to First Bowel Movement

  We will monitor the patients' bowel movements and record the time to the first bowel movement in hours

  1 week

Study Arms (1)

Naloxone

EXPERIMENTAL

1 mg/ml oral solution administered enterally every eight hours for 48 hours

Drug: Naloxone

Interventions

Naloxone DRUG

Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids)

Naloxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (7)

• 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.

  PMID: 19250137 BACKGROUND

• 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.

  PMID: 18828197 BACKGROUND

• 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.

  PMID: 24184650 BACKGROUND

• 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.

  PMID: 18762438 BACKGROUND

• 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.

  PMID: 10601678 BACKGROUND

• 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.

  PMID: 8800821 BACKGROUND

• 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.

  PMID: 11212050 BACKGROUND

MeSH Terms

Conditions

Ileus

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Russell Nockels, M.D.
• Organization: Loyola University Medical Center

neurocare@nch.org

847-618-9565

Study Officials

• Russell Nockels, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants who agree to participate in the study and meet the inclusion and exclusion criteria may receive the planned study intervention.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: September 20, 2017
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)