NCT07639281

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Feb 2024Jan 2027

Study Start

First participant enrolled

February 14, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

Opioidpostoperativeventral hernia repair

Outcome Measures

Primary Outcomes (1)

  • Quantity of Opioid Pills taken after Ventral Hernia Repair

    up to 6 weeks

Study Arms (2)

Opioid and Surgery Education Video

EXPERIMENTAL
Behavioral: Opioid and Surgery Education Video

Surgery Education Video

PLACEBO COMPARATOR
Behavioral: Surgery Education Video

Interventions

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.

Opioid and 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.

Surgery Education Video

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ventral Hernia Repair
  • years of age
  • Patient must give informed consent to participate
  • Participant must be able to interact and understand video being shown to them

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator-Medical Student

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

February 14, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations