NCT03176316

The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ileus
• Fusion of Spine

Interventions

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

Timeline

• Start date: 2017-09-20
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2017-06-05
• Last updated: 2024-07-01
• Results posted: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study