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Recruiting Phase 4 NCT05722002

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

Phase 4 – monitoring after market approval
Conditions: Surgery Pain, Postoperative

Sponsor: University of Michigan

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
NSAID
DRUG
Opioid
DRUG
Acetaminophen
DRUG
Locations 8
Canada (2)
Women's College Hospital
Toronto , Ontario
Unity Health Toronto
Toronto , Ontario
United States (6)
University of Michigan
Ann Arbor , Michigan
Cooper University Health Care
Camden , New Jersey
University of North Carolina Hospitals
Chapel Hill , North Carolina
Henry Ford Health System
Detroit , Michigan
Temple University - Temple Health
Philadelphia , Pennsylvania
Washington University in Saint Louis
St Louis , Missouri
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.02.2023
Completion date
01.07.2027
Registry ID
NCT05722002
Source
clinicaltrials.gov
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