NCT05722002

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

Name: Clinical Trial NCT05722002
Creator: University of Michigan
Keywords: Surgery,Pain, Postoperative, NSAID, Phase 4, drug, clinical trial, Canada,United States of America

University of Michigan·Phase 4·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Surgery,Pain, Postoperative
Drug/Device/Intervention: NSAID
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: University of Michigan
Location: Ann Arbor,Detroit,Saint Louis,Toronto, Canada,United States of America

Timeline & enrollment

Phase: Phase 4
Start date: Feb 06, 2023
End date: Oct 01, 2024
Enrollment: 900 participants

Primary outcome

Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery,Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery

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.

ICD-10 classifications

During surgical operationDuring surgical operationDuring surgical operationOther surgical proceduresDuring other surgical and medical care

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05722002
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05722002 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Michigan and is currently Recruiting. The study focuses on Surgery,Pain, Postoperative. Target enrollment is 900 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.