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NCT05722002PHASE4Recruiting

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

University of Michigan

Start Date

2/6/2023

Completion Date

7/1/2027

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

NSAID

DRUG

Opioid

DRUG

Acetaminophen

Interested in This Trial?

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Conditions

SurgeryPain, Postoperative

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Washington University in Saint Louis

St Louis, Missouri 63130

United States

Cooper University Health Care

Camden, New Jersey 08103

United States

University of North Carolina Hospitals

Chapel Hill, North Carolina 27599

United States

Temple University - Temple Health

Philadelphia, Pennsylvania 19140

United States

Women's College Hospital

Toronto, Ontario M5S 1B2

Canada

Unity Health Toronto

Toronto, Ontario

Canada