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

Description

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

Surgery, Pain, Postoperative

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Saint Louis

Washington University in Saint Louis, Saint Louis, Missouri, United States, 63130

Philadelphia

Temple University - Temple Health, Philadelphia, Pennsylvania, United States, 19140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Mark Bicket, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-10