Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Phase 4
900
about 3.7 years
18+
6 sites in MI, MO, NC +2
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Acetaminophen
- 2.Take NSAID
- 3.Take Opioid
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
paracetamol (Reduces fever and pain (mechanism not fully understood))
oral
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