N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: University of Michigan • ClinicalTrials.gov ID: NCT05722002

Registry updated: 2026-08-28
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

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.

Interventions

  • NSAID (Drug)
    Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Ibuprofen 600 milligram (mg) by mouth every six hours as needed for pain (10 doses) * Celecoxib 400 mg by mouth once then 200 mg every twelve hours as needed for pain (10 doses) * Naproxen 500 mg by mouth once then 250 mg by mouth every eight hours as needed for pain (10 doses)
  • Opioid (Drug)
    Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Oxycodone 5 mg by mouth every four to six hours as needed for pain, 10 doses * Morphine 7.5 mg by mouth every four to six hours as needed for pain, 10 doses * Hydromorphone 2 mg by mouth every four to six hours as needed for pain, 10 doses
  • Acetaminophen (Drug)
    Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).

Eligibility criteria

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.

Conditions

Surgery Pain, Postoperative

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record