- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07639281
Opioid Education Ventral Hernia Repair
The Effect on Educational Videos on Opioid Use
The goal of this study is to learn if opioid education before surgery affects prescribed opioid use after surgery in participants who are undergoing a ventral hernia repair. The main question it aims to answer is, does opioid education before surgery lower the number of opioid pills taken during recovery after a ventral hernia repair? Researchers will compare participants who watch an opioid education video before surgery to participants who watch a ventral hernia repair education video before surgery to see if those who watch an opioid education video take less prescribed opioid pills during recovery.
Participants will watch a roughly 2-minute video in office the day their ventral hernia repair is scheduled, watch the same video the day of their surgery and be asked to report how many prescription opioid pills they took during recovery and return any left-over prescription opioid pills for disposal at their 1 month follow up appointment.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ventral Hernia Repair
- 18-85 years of age
- Patient must give informed consent to participate
- Participant must be able to interact and understand video being shown to them
Exclusion Criteria:
- Opioid Use Disorder Diagnosis
- Current Use of Opioids or pre-existing narcotic prescription that is used on a regular basis
- First language not English
- Having an infected mesh and/or enterocutaneous fistula
- Having another concurrent gastrointestinal operation during the ventral hernia repair
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Opioid and Surgery Education Video
|
This video educates patients on what a ventral hernia repair is as well as common side effects of opioid use, what opioid tolerance is and how it develops, what opioid withdrawal presents as, how to prevent opioid-induced dependence and addiction, and how to safely dispose of opioid drugs.
|
|
Placebo Comparator: Surgery Education Video
|
This video educates patients on what a ventral hernia repair is and the difference between laparoscopic and open repair.
Contains no new information that should have already been discussed between patient and physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quantity of Opioid Pills taken after Ventral Hernia Repair
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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