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

Last updated: October 14, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

4

Condition

Surgery

Treatment

Acetaminophen

NSAID

Opioid

Clinical Study ID

NCT05722002
HUM00215416
CER-2021C1-22398
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No significant analgesic medication use before surgery: For this study, significantanalgesic medication use before surgery as use of prescriptions for opioid or NSAIDmedications 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-commonlow-risk surgical procedures will include laparoscopic gallbladder removal, inguinalhernia repair, and breast lumpectomy.

Exclusion

Exclusion Criteria:

  • Anticipated other surgery within 6 months or anticipated life expectancy of lessthan 6 months

  • Patients with contraindications to NSAID drugs in the NSAID arm, opioid drugs in theOPIOID arm, or acetaminophen will be excluded. There are specific contraindicationsthat will be reviewed per protocol.

Study Design

Total Participants: 900
Treatment Group(s): 3
Primary Treatment: Acetaminophen
Phase: 4
Study Start date:
February 06, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Unity Health Toronto

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Women's College Hospital

    Toronto, Ontario M5S 1B2
    Canada

    Site Not Available

  • Unity Health Toronto

    Toronto 6167865, Ontario 6093943
    Canada

    Active - Recruiting

  • Women's College Hospital

    Toronto 6167865, Ontario 6093943 M5S 1B2
    Canada

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University in Saint Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University in Saint Louis

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cooper University Health Care

    Camden 4501018, New Jersey 5101760 08103
    United States

    Active - Recruiting

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina Hospitals

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Temple University - Temple Health

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Temple University - Temple Health

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Active - Recruiting

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