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

University of Michigan
NCT IDNCT05722002ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

900

Study length

about 3.7 years

Ages

18+

Locations

6 sites in MI, MO, NC +2

About this study

This trial is testing two different ways to manage pain after surgery. Participants who have gallbladder removal, hernia repair, or breast lump removal will be included. Eligible people will be randomly assigned to either a group taking NSAIDs plus acetaminophen, or a group taking low-dose opioids plus acetaminophen. The goal is to compare the effectiveness and safety of these two approaches.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Acetaminophen
  • 2.Take NSAID
  • 3.Take Opioid
PhasePhase 4
DrugAcetaminophen
Routeoral
Primary goalPain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low4%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

paracetamol (Reduces fever and pain (mechanism not fully understood))

Drug routes

oral

Endpoints

Primary: 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

Secondary: Acute pain based on The Michigan Body Map, Chronic pain based on Body Map, Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery, Clinically important adverse events, Healthcare Utilization related to pain at 1 month, Healthcare Utilization related to pain at 6 months, PROMIS Pain Interference 4a, PROMIS Preference score 29+2 Profile v2.1