No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The investigators hypothesize that not prescribing opioids after uncomplicated, outpatient IHR will be non-inferior to prescribing opioids (5 tablets of Oxycodone, 5mg; or surgeon preference for intolerance) with respect to requests for opioid refills. Additionally, the investigators believe there will be no significant difference in postoperative readmission for pain quality of life at 30 days in either group.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients aged 18 years or older
• Patients undergoing elective unilateral or bilateral inguinal hernia repairs
• Patients able to tolerate general anesthesia
Locations
United States
California
MemorialCare
RECRUITING
Fountain Valley
Michigan
Corewell Health
RECRUITING
Royal Oak
Ohio
Cleveland Clinic Center for Abdominal Core Health
RECRUITING
Cleveland
University Hospitals
RECRUITING
Cleveland
South Carolina
Prisma Health
RECRUITING
Greenville
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Clayton C Petro, MD
petroc@ccf.org
216 445-0053
Backup
Kimberly Woo, MD
wook2@ccf.org
216-399-9672
Time Frame
Start Date: 2023-07-10
Estimated Completion Date: 2027-07
Participants
Target number of participants: 904
Treatments
Other: Minimal Opioids
Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain
Other: No opioids
Standard of care
Related Therapeutic Areas
Sponsors
Leads: Clayton Petro