Fusion of Spine, Ileus
Conditions
Keywords
ileus, fusion of spine
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.
Interventions
DRUGNaloxone
Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids)
Sponsors
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All participants who agree to participate in the study and meet the inclusion and exclusion criteria may receive the planned study intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Bowel Movement | 1 week | We will monitor the patients' bowel movements and record the time to the first bowel movement in hours |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Naloxone Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids). The study administers 1 mg/ml oral solution enterally every eight hours for 48 hours. | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Naloxone |
|---|---|
| Age, Continuous | 65.91 years STANDARD_DEVIATION 9.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 53 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
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
Population: The research team collected outcome data on one participant. The Institutional Review Board terminated the study early due to non-compliance with continuing review requirements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naloxone | Time to First Bowel Movement | 43.62 Hours |