A Phase 4 interventional study of Naloxone in Ileus and Fusion of Spine, sponsored by Loyola University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Loyola University · Phase 4, Interventional, and Prevention
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.
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.
Exclusion Criteria:
1 mg/ml oral solution administered enterally every eight hours for 48 hours
Drug: Naloxone
Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids)
Time to First Bowel Movement
We will monitor the patients' bowel movements and record the time to the first bowel movement in hours
Time frame: 1 week
Recruitment began on September 20, 2017 and ended on February 20, 2020 when the Institutional Review Board placed the project on administrative hold. Recruitment occurred at a Loyola University Medical Center clinic.
| Milestone | Naloxone |
|---|---|
| Started | 53 |
| Completed | 53 |
| Not completed | 0 |
We will monitor the patients' bowel movements and record the time to the first bowel movement in hours
| Hours | Naloxone |
|---|---|
| Time to First Bowel Movement | 43.62 |
Collected over Adverse event data were collected for 2 years and 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naloxone | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Continuous(years) | Naloxone |
|---|---|
| Mean | 65.91 ± 9.99 |
| Sex: Female, Male(Participants) | Naloxone |
|---|---|
| Female | 25 |
| Male | 28 |
| Race (NIH/OMB)(Participants) | Naloxone |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 31 |
| Region of Enrollment(Participants) | Naloxone |
|---|---|
| United States | 53 |
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Plan to share: No — There are no plans to share individual participant data with other researchers
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Loyola University