Comparing no opioids to minimal opioids after inguinal hernia repair
No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
PHASE4 · The Cleveland Clinic · NCT05929937
This study is testing if not giving opioids or giving just a small amount after inguinal hernia surgery helps manage pain just as well for patients.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 904 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 6 sites (Fountain Valley, California and 5 other locations) |
| Trial ID | NCT05929937 on ClinicalTrials.gov |
What this trial studies
This study investigates whether not prescribing opioids after uncomplicated outpatient inguinal hernia repair is as effective as prescribing a minimal amount of opioids in managing postoperative pain. Patients undergoing elective unilateral or bilateral inguinal hernia repairs will be randomly assigned to receive either no opioids or a small prescription of opioids. The study aims to evaluate the need for opioid refills and assess postoperative pain quality of life at 30 days. Data will be collected through the ACHQC database and REDCap® to ensure comprehensive follow-up and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective inguinal hernia repairs who can tolerate general anesthesia.
Not a fit: Patients with chronic pain requiring opioids, those unable to tolerate general anesthesia, or those needing extensive surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce opioid prescriptions and associated risks while effectively managing postoperative pain.
How similar studies have performed: Previous studies have shown promising results in reducing opioid use after similar surgical procedures, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18 years or older * Patients undergoing elective unilateral or bilateral inguinal hernia repairs * Patients able to tolerate general anesthesia Exclusion Criteria: * Patients who cannot tolerate general anesthesia, * 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
Where this trial is running
Fountain Valley, California and 5 other locations
- MemorialCare — Fountain Valley, California, United States (RECRUITING)
- Corewell Health — Royal Oak, Michigan, United States (RECRUITING)
- University Hospitals — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States (RECRUITING)
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (RECRUITING)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Clayton C Petro, MD — The Cleveland Clinic
- Study coordinator: Clayton C Petro, MD
- Email: petroc@ccf.org
- Phone: 216 445-0053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain, Inguinal Hernia