The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Time to First Bowel Movement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Naloxone
1 mg/ml oral solution administered enterally every eight hours for 48 hours
Intervention: Naloxone (Drug)
Outcomes
Primary Outcomes
Time to First Bowel Movement
Time Frame: 1 week
We will monitor the patients' bowel movements and record the time to the first bowel movement in hours
Secondary Outcomes
No secondary outcomes reported