NCT05722002 Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
| NCT ID | NCT05722002 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 900 participants in total. It began in 2023-02-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mark Bicket, MD, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05722002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05722002 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05722002 currently recruiting?
Yes, NCT05722002 is actively recruiting participants. Contact the research team at sarahmcl@med.umich.edu for enrollment information.
Where is the NCT05722002 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Detroit, United States, St Louis, United States, Camden, United States and 4 additional locations.
Who is sponsoring the NCT05722002 clinical trial?
NCT05722002 is sponsored by University of Michigan. The principal investigator is Mark Bicket, MD, PhD at University of Michigan. The trial plans to enroll 900 participants.