Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
NCT ID: NCT05722002
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
900 participants
INTERVENTIONAL
2023-02-06
2026-10-31
Brief Summary
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It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NSAID regimen
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
NSAID
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)
Acetaminophen
Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
Opioid regimen
Opioid
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
Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
Interventions
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NSAID
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
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
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
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Michigan
OTHER
Responsible Party
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Mark Bicket, MD, PhD
Associate Professor
Principal Investigators
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Mark Bicket, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Bicket MC, Ladha KS, Haroutounian S, McFarlin K, Neff M, McDuffie RL, Waljee JF, Wijeysundera DN, Brummet C, Li Y; CARES Investigators. Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES): protocol for a pragmatic, international multicentre randomised trial. BMJ Open. 2025 Apr 5;15(4):e099925. doi: 10.1136/bmjopen-2025-099925.
Other Identifiers
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CER-2021C1-22398
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00215416
Identifier Type: -
Identifier Source: org_study_id
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