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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Missouri
Washington University in Saint Louis
RECRUITING
St Louis
North Carolina
University of North Carolina Hospitals
ACTIVE_NOT_RECRUITING
Chapel Hill
New Jersey
Cooper University Health Care
RECRUITING
Camden
Pennsylvania
Temple University - Temple Health
RECRUITING
Philadelphia
Other Locations
Canada
Unity Health Toronto
RECRUITING
Toronto
Women's College Hospital
RECRUITING
Toronto
Contact Information
Primary
Sarah Clark, BA
sarahmcl@med.umich.edu
734-232-0324
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2026-10
Participants
Target number of participants: 900
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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