Recruiting

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

Sponsor:

University of Michigan

Code:

NCT05722002

Conditions

Surgery

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NSAID

Opioid

Acetaminophen

Study Details

Brief summary:

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

Study ID

NCT05722002

Start date

Feb 6, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Feb 10, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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).

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 ]
Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery [ Time Frame: 7 days post surgery ]

Central Contacts and Locations

Central contacts

Sarah Clark, BA

734-232-0324 sarahmcl@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sarah Clark

734-232-0324 sarahmcl@med.umich.edu

Principal Investigator:

Mark Bicket, MD, PhD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Kasia Nowak, PhD

313-771-7128 knowak2@hfhs.org

Principal Investigator:

Kellie McFarlin, MD, FACS

Washington University in Saint Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Justin Stout, MS

314-273-2455 justinjstout@wustl.edu

Principal Investigator:

Simon Haroutounian, PhD, MSc

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Asia Vincent

800-826-6737 vincent-asia@CooperHealth.edu

University of North Carolina Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Karen Van Manen, PhD

919-843-6572 karen_vanmanen@med.unc.edu

Temple University - Temple Health

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Anamarys Arroyo-Lloret

215-643-5067 anamarys.arroyo-lloret@tuhs.temple.edu

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Didem Bozak

416-323-6008 didem.bozak@wchospital.ca

Principal Investigator:

Karim Ladha, MD, MSc, AB, FRCPC

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada

Contacts

Janneth P Canizares

416-864-6060 janneth.pazmino-canizares@unityhealth.to

Principal Investigator:

Duminda Wijeysundera, MD, PhD

More Information

Sponsor

University of Michigan

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

Medications after surgery
NSAIDS
Acetaminophen
Opioids
laparoscopic gallbladder removal
inguinal hernia repair
breast lumpectomy
Analgesics, non-narcotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-28.