No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
NCT ID: NCT05929937
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
904 participants
INTERVENTIONAL
2023-07-10
2027-07-31
Brief Summary
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Detailed Description
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Baseline information, operative details, and 30-day outcomes are already captured within the ACHQC database, allowing for follow-up, and data capture with decreased effort outside of routine care. Randomization data will be captured and stored in REDCap®.
Baseline patient demographics will be obtained at initial patient recruitment, and baseline ACHQC questionnaires will be completed following patient recruitment. All operative details are already routinely collected and stored in the ACHQC database. Patient-reported quality of life will also be assessed at baseline and at 30 days using the EuraHS Quality Of Life survey tool, which is collected for all patients entered into the ACHQC as part of the ACHQC Inguinal Hernia Postoperative Assessment. Patients will be required to complete these forms at each clinic visit, or via telephone contact, as this is standard procedure for all patients entered into the ACHQC. At the time of the one-month follow-up clinic visits, a routine physical examination will be performed on all patients.
Outcomes to be investigated:
* Specific Aim #1: To determine if the use of post-operative use of opioids results in a difference in rate of opioid refills/requests when compared to those not initially prescribed opioids.
* Specific Aim #2: To determine if the use of post-operative use of opioids results in a difference in Patient-Reported Outcome Measurement Information System (PROMIS Pain Intensity) scores at the 1 month follow up visit post-operatively when compared to those not prescribed opioids.
* Specific Aim #3: To determine if the use of post-operative use of opioids results in a difference in EuraHS (European registry for abdominal wall hernias) Quality of Life (QoL) scores at the 1 month follow up visit post-operatively when compared to those not prescribed opioids.
* Specific Aim #4: To determine if the use of post-operative use of opioids results in a difference in all 30-day complications when compared to those not prescribed opioids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Minimal Opioids
Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain
Opioids
Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance)
No opioids
Standard of care
No opioids
Standard of care, patients will not receive a prescription for opioids.
Interventions
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Opioids
Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance)
No opioids
Standard of care, patients will not receive a prescription for opioids.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective unilateral or bilateral inguinal hernia repairs
* Patients able to tolerate general anesthesia
Exclusion Criteria
* Patients who cannot tolerate opioids or NSAIDS,
* Patients on opioids for chronic pain management (defined as near daily use within 90 days),
* Patients who undergo surgeries requiring extensive dissection/hernia sac reduction, or additional procedures,
* Patients requiring inpatient admission postoperatively
* Patients who are not able to understand and sign a written consent form
18 Years
ALL
No
Sponsors
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Clayton Petro
OTHER
Responsible Party
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Clayton Petro
Assistant Professor of Surgery Lerner College of Medicine
Principal Investigators
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Clayton C Petro, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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MemorialCare
Fountain Valley, California, United States
Corewell Health
Royal Oak, Michigan, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
North York General Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Todd Harris, MD
Role: primary
Study Coordinator
Role: primary
Joshua Lyons, MD
Role: primary
Clayton C Petro, MD
Role: primary
Study Coordinator
Role: primary
Kaela E. Blake, MD
Role: primary
Rana Higgins, MD
Role: primary
Megan Melland-Smith, MD
Role: primary
Other Identifiers
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23-189
Identifier Type: -
Identifier Source: org_study_id