NCT05722002

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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)
DRUG	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
DRUG	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).

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2023-02-10
• Last updated: 2026-04-17

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study