The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus (FusionIleus)
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|ClinicalTrials.gov Identifier: NCT03176316|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ileus Fusion of Spine||Drug: Naloxone||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A paired t-test will be used to estimate the mean difference in hours to first feces between the active cohort and historical control cohort. If necessary, a Wilcoxon signed ranks test will be used to compare the two distributions.|
|Masking:||None (Open Label)|
|Official Title:||The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus|
|Actual Study Start Date :||January 2, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours
Blinding/labeling/preparation of agents: No blinding is required in this study. The study drug will be prepared, unit dose labelled, and patient labelled according to institutional protocols.
Storage: Secured at room temperature in the central pharmacy then dispensed as a patient specific supply and stored at room temperature the automated dispensing cabinet. No more than a 24 hour supply will be dispensed at any given time.
Administration: 1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours
- Time to first bowel movement [ Time Frame: 1 week ]We will be monitoring the patients bowel movements and recording the time to the first bowel movement
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176316
|Contact: Kevin Swong, MDemail@example.com|
|Contact: Stephen Johans, MDfirstname.lastname@example.org|
|United States, Illinois|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Russell Nockels, MD||Loyola University|