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

Study acronym: CARES
StatusRecruiting
PhasePhase 4
Started2023-02-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 41 days later Dec 2026 → Feb 10, 2027
See other at-risk trials from University of Michigan

Amendment history

2026-08-25
notable
Study Status, Oversight v8
Primary completion pushed: 2026-12 → 2027-02-10
Completion pushed: 2027-07 → 2027-08-31
2026-04-13
minor
Study Status, Oversight v7
Primary completion date2026-04→2026-12
Completion date2026-10→2027-07
2025-10-14
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 8 sites
2025-08-01
minor
Study Status, Contacts/Locations v5
Study sites5→8
2025-03-05
minor
Study Status, Contacts/Locations, IPDSharing v4
Study sitescontacts updated at 5 of 5 sites
Show 3 earlier versions
2025-02-11
minor
Study Status v3
Primary completion date2025-04→2026-04
Completion date2025-10→2026-10
2024-10-29
minor
Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v2
Primary completion date2024-10→2025-04
Completion date2024-10→2025-10
Study sites4→5
2024-02-12
minor
Study Status v1
Re-verified, no change to tracked fields
2023-02-09
minor
Original filing
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.
Trial Details
NCT Number NCT05722002
Lead Sponsor University of Michigan
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Surgery, Pain, Postoperative
Enrollment 900 participants
Start Date 2023-02-06
Primary Completion 2027-02-10 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-28