The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus (FusionIleus)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
53 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Stephen Johans, MD; Kevin Swong, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal