Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05722002

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

Led by University of Michigan · Updated on 2026-04-17

900

Participants Needed

8

Research Sites

229 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • No significant use of opioid or NSAID prescriptions in the past 30 days
  • No over-the-counter NSAID use on more than 7 of the past 30 days
  • Scheduled for one of these low-risk surgeries: laparoscopic gallbladder removal, inguinal hernia repair, or breast lumpectomy
Not Eligible

You will not qualify if you...

  • Planned additional surgery within 6 months or life expectancy less than 6 months
  • Known contraindications to NSAIDs if assigned to NSAID group
  • Known contraindications to opioids if assigned to opioid group
  • Known contraindications to acetaminophen

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

2

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

3

Washington University in Saint Louis

St Louis, Missouri, United States, 63130

Actively Recruiting

4

Cooper University Health Care

Camden, New Jersey, United States, 08103

Actively Recruiting

5

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

6

Temple University - Temple Health

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

7

Women's College Hospital

Toronto, Ontario, Canada, M5S 1B2

Actively Recruiting

8

Unity Health Toronto

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

S

Sarah Clark, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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