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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05722002
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Pain, Postoperative
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Feb 6, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: NSAID regimen
    Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
  • Other: Opioid regimen

Primary Outcome Measure

Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery [ Time Frame: 7 days post surgery ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Sarah Clark
[email protected]
734-232-0324
Mark Bicket, MD, PhD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Kasia Nowak, PhD
[email protected]
313-771-7128
Kellie McFarlin, MD, FACS (PRINCIPAL_INVESTIGATOR)
Washington University in Saint LouisSt LouisMissouri63130
Justin Stout, MS
[email protected]
314-273-2455
Simon Haroutounian, PhD, MSc (PRINCIPAL_INVESTIGATOR)
Cooper University Health CareCamdenNew Jersey08103
Asia Vincent
[email protected]
800-826-6737
Ludmil Mitrev, MD (SUB_INVESTIGATOR)
University of North Carolina HospitalsChapel HillNorth Carolina27599
Karen Van Manen, PhD
[email protected]
919-843-6572
Matthew Mauck, MD, PhD (SUB_INVESTIGATOR)
Temple University - Temple HealthPhiladelphiaPennsylvania19140
Anamarys Arroyo-Lloret
[email protected]
215-643-5067
Ellen Hauck, DO (SUB_INVESTIGATOR)

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University of Michigan· Ann Arbor, MIHenry Ford Health System· Detroit, MIWashington University in Saint Louis· St Louis, MOCooper University Health Care· Camden, NJUniversity of North Carolina Hospitals· Chapel Hill, NCTemple University - Temple Health· Philadelphia, PA

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