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Comparing Pain Relief After Surgery (CARES) Trial

This study, called the CARES Trial, is comparing two common ways to manage pain after certain surgeries like gallbladder removal, hernia repair, or breast lump removal. You would receive either a Non-Steroidal Anti-Inflammatory Drug (NSAID) like ibuprofen or celecoxib, plus acetaminophen (Tylenol), OR a low-dose opioid like oxycodone, morphine, or hydromorphone, plus acetaminophen. Researchers want to see which approach works better for pain and has fewer side effects over 7 days after surgery. They are looking for about 900 participants aged 18 and older who haven't used significant pain medication recently.

Study design
This is an interventional study where participants will be randomly assigned to one of two treatment groups. Approximately 900 people are planned to join.
What's involved
You would receive specific pain medications after surgery for up to 7 days. Your pain intensity and any medication side effects would be measured over this 7-day period.
Compensation
Not stated in the trial record.
Follow-up
Your pain and any medication-related side effects will be monitored for 7 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05722002

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Michigan
~900 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NSAIDOpioidAcetaminophen

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery
Measured over 7 days post surgery
+1 more outcome measured

Conditions

Surgery
Pain, Postoperative

Explore related trials

Breast CarcinomaGallbladder DisorderInguinal Hernia

Where it's being run

8 sites across 6 states
Michigan2
Ontario2
Missouri1
New Jersey1
North Carolina1
Pennsylvania1

Study leadership

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

Who to contact

Sarah Clark, BA
[email protected]
734-232-0324
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery7 days post surgery

    This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.

  • Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery7 days post surgery

    Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 7 days post surgery.