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Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Sponsor: University of Michigan
Summary
This trial is being completed to compare two commonly used options to treat pain after surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen). It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2023-02-06
Completion Date
2026-10
Last Updated
2025-10-16
Healthy Volunteers
No
Conditions
Interventions
NSAID
Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Ibuprofen 600 milligram (mg) by mouth every six hours as needed for pain (10 doses) * Celecoxib 400 mg by mouth once then 200 mg every twelve hours as needed for pain (10 doses) * Naproxen 500 mg by mouth once then 250 mg by mouth every eight hours as needed for pain (10 doses)
Opioid
Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Oxycodone 5 mg by mouth every four to six hours as needed for pain, 10 doses * Morphine 7.5 mg by mouth every four to six hours as needed for pain, 10 doses * Hydromorphone 2 mg by mouth every four to six hours as needed for pain, 10 doses
Acetaminophen
Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
Locations (8)
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University in Saint Louis
St Louis, Missouri, United States
Cooper University Health Care
Camden, New Jersey, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Temple University - Temple Health
Philadelphia, Pennsylvania, United States
Women's College Hospital
Toronto, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada