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Local Anesthetic

Local Anesthesia for Preventing Atrial Fibrillation After Cardiac Surgery

Phase 4
Recruiting
Led By James Flaherty, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
Be older than 18 years old
Must not have
Contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic)
History of atrial fibrillation or flutter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24, 48, 72, 96, and 120 hours post-operatively
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing if a painkiller can also help prevent heart problems after surgery.

Who is the study for?
This trial is for adults needing certain heart surgeries (CABG, aortic or mitral valve replacement) without emergency conditions. Candidates must not have had atrial fibrillation before, severe heart pump dysfunction, an allergy to local anesthetics, bleeding disorders, be severely overweight or pregnant.
What is being tested?
The study tests if injecting Ropivacaine (a numbing medication) near the spine before and after surgery can prevent new cases of irregular heartbeat (atrial fibrillation) in patients having their first bypass or heart valve surgery.
What are the potential side effects?
Ropivacaine may cause side effects like low blood pressure, dizziness, nausea, vomiting, numbness beyond the targeted area and rarely allergic reactions. Serious complications are uncommon but can include nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for heart surgery, such as bypass or valve replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have block placement due to an allergy to local anesthetics or bleeding issues.
Select...
I have a history of irregular heartbeats.
Select...
I have been diagnosed with an infection in the heart's inner lining.
Select...
I am scheduled for or have had a second surgery.
Select...
I require emergency surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24, 48, 72, 96, and 120 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, 72, 96, and 120 hours post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of New-Onset Atrial Fibrillation (NOAF)
Secondary study objectives
30-Day Mortality
Average pain score
Block performance time
+10 more

Awards & Highlights

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Participants in this group will receive the intervention.
Group II: ControlActive Control1 Intervention
Participants in this group will receive no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine 0.2% Injectable Solution
2021
Completed Phase 4
~600

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,427 Previous Clinical Trials
1,620,543 Total Patients Enrolled
James Flaherty, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
77 Total Patients Enrolled
~4 spots leftby Jul 2025
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