← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

CARES 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.Check my eligibility

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.See study design

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.

CARES Trial 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.

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months after surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+11 more

CARES 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

Acetaminophen

2017

Completed Phase 4

~2030

Opioid

2008

Completed Phase 4

~2450

NSAID

2016

Completed Phase 4

~10200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,238 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,996,558 Total Patients Enrolled

Mark Bicket, MD, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

NSAID (Non-Steroidal Anti-Inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05722002 — Phase 4

Postoperative Pain Research Study Groups: NSAID regimen, Opioid regimen

Postoperative Pain 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently room for enrolment in this clinical research?

"The clinical trial is actively accepting patients at this time, according to information available on the website clinicialtrials.gov. It has been active since February 6th 2023 and was last updated two days ago."

Answered by AI

How risky is this intervention for individuals?

"The safety of this approved treatment has been evaluated to be a 3 on our team's rating scale, as it is currently being trialled in Phase 4."

Answered by AI

How many individuals have been enrolled in this trial to date?

"Indeed, the trial is still available for enrolment. It was initially posted on February 6th 2023 and subsequently updated on the 9th of that same month. The research team needs to enlist 900 volunteers across 4 medical settings."

Answered by AI

To what extent has this experiment been disseminated among medical facilities?

"Patients are being recruited from 4 distinct medical sites, namely: Detroit, Saint Louis, Toronto and additional locations. It is highly advisable to choose the closest clinic in order to reduce time spent travelling if one decides to partake in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mark Bicket, MD, PhD 2023. "Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722002.