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The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

NCT03176316 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-07-01

Study results available
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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

Interventions

DRUG

Naloxone

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

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Russell Nockels, MD · Loyola University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176316 on ClinicalTrials.gov