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

Recruiting now · Phase 4

Conditions studied: Surgery, Pain, Postoperative

In brief

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 facts

Study ID

NCT05722002

Run by

University of Michigan

People needed

900

Starts

2023-02-06

Expected to finish

2027-07-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Washington University in Saint Louis — St Louis, Missouri, United States (enrolling)
• Cooper University Health Care — Camden, New Jersey, United States (enrolling)
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States (enrolling)
• Temple University - Temple Health — Philadelphia, Pennsylvania, United States (enrolling)
• Women's College Hospital — Toronto, Ontario, Canada (enrolling)
• Unity Health Toronto — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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