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

Last updated: March 5, 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

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University in Saint Louis

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Temple University - Temple Health

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

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