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Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Michigan
NCT05722002 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * No significant analgesic medication use before surgery: For this study, significant analgesic medication use before surgery as use of prescriptions for opioid or NSAID medications in the past 30 days, or over-the-counter NSAID use on greater than 7 of 30 past days, as reported by the patient. * One of three common low-risk surgical procedures: For this study, the three-common low-risk surgical procedures will include laparoscopic gallbladder removal, inguinal hernia repair, and breast lumpectomy. Exclusion Criteria: * Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months * Patients with contraindications to NSAID drugs in the NSAID arm, opioid drugs in the OPIOID arm, or acetaminophen will be excluded. There are specific contraindications that will be reviewed per protocol.
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What it tests

  • NSAID
  • Opioid
  • Acetaminophen
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Where

8 sites
University of Michigan
Ann Arbor, United States
Henry Ford Health System
Detroit, United States
Washington University in Saint Louis
St Louis, United States
Cooper University Health Care
Camden, United States
University of North Carolina Hospitals
Chapel Hill, United States
Temple University - Temple Health
Philadelphia, United States
Women's College Hospital
Toronto, Canada
Unity Health Toronto
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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