RECRUITING

No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

Quick Facts

Study Start:2023-07-10
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05929937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients aged 18 years or older
  2. * Patients undergoing elective unilateral or bilateral inguinal hernia repairs
  3. * Patients able to tolerate general anesthesia
  1. * Patients who cannot tolerate general anesthesia,
  2. * Patients who cannot tolerate opioids or NSAIDS,
  3. * Patients on opioids for chronic pain management (defined as near daily use within 90 days),
  4. * Patients who undergo surgeries requiring extensive dissection/hernia sac reduction, or additional procedures,
  5. * Patients requiring inpatient admission postoperatively
  6. * Patients who are not able to understand and sign a written consent form

Contacts and Locations

Study Contact

Clayton C Petro, MD
CONTACT
216 445-0053
petroc@ccf.org
Kimberly Woo, MD
CONTACT
216-399-9672
wook2@ccf.org

Principal Investigator

Clayton C Petro, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

MemorialCare
Fountain Valley, California, 92708
United States
University Hospitals
Cleveland, Ohio, 44106
United States
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Clayton Petro

  • Clayton C Petro, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10
Study Completion Date2027-07

Study Record Updates

Study Start Date2023-07-10
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Postoperative Pain
  • Inguinal Hernia