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Non-Steroidal Anti-Inflammatory Drug

Pain Medication for Postoperative Pain (CARES Trial)

Phase 4
Recruiting
Led By Mark Bicket, MD, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No significant analgesic medication use before surgery: 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.
Be older than 18 years old
Must not have
Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares meds used to treat pain after surgery to see which is better and has fewer side effects. Eligible patients will be randomized to one of two groups.

Who is the study for?
The CARES trial is for patients having low-risk surgeries like gallbladder removal, hernia repair, or breast lump removal. They must not have used significant pain medication recently and should be free from other surgeries or life-threatening conditions in the next 6 months. Those with specific allergies to NSAIDs, opioids, or acetaminophen can't join.
What is being tested?
This study compares two pain management strategies after surgery: one group will receive NSAIDs plus acetaminophen while the other gets low-dose opioids plus acetaminophen. Patients are randomly assigned to these groups to see which has better outcomes and fewer side effects.
What are the potential side effects?
Possible side effects may include gastrointestinal issues with NSAIDs and risks of addiction or sedation with opioids. Acetaminophen could cause liver damage if taken in high doses. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't used strong painkillers or NSAIDs much before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not expect to have any surgeries in the next 6 months and believe I will live longer than 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
+10 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Opioid regimenExperimental Treatment2 Interventions
Group II: NSAID regimenExperimental Treatment2 Interventions
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opioid
2008
Completed Phase 4
~2450
Acetaminophen
2017
Completed Phase 4
~2030
NSAID
2016
Completed Phase 4
~10200

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,863 Previous Clinical Trials
6,440,681 Total Patients Enrolled
24 Trials studying Infections
69,666 Patients Enrolled for Infections
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,359 Total Patients Enrolled
5 Trials studying Infections
94,952 Patients Enrolled for Infections
Mark Bicket, MD, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
1,000 Total Patients Enrolled

Media Library

NSAID (Non-Steroidal Anti-Inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05722002 — Phase 4
Infections Research Study Groups: NSAID regimen, Opioid regimen
Infections Clinical Trial 2023: NSAID Highlights & Side Effects. Trial Name: NCT05722002 — Phase 4
NSAID (Non-Steroidal Anti-Inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722002 — Phase 4
~108 spots leftby Apr 2025
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