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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24, 48, 72, 96, and 120 hours post-operatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48, 72, 96, and 120 hours post-operatively

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

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

Primary outcome measures

Incidence of New-Onset Atrial Fibrillation (NOAF)

Secondary outcome measures

30-Day Mortality

Average pain score

Block performance time

+10 more

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

~530

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,379 Previous Clinical Trials

1,588,466 Total Patients Enrolled

James Flaherty, MDPrincipal InvestigatorUniversity of Minnesota

1 Previous Clinical Trials

77 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have been enrolled in this experiment?

"Affirmative. According to the data accessible on clinicaltrials.gov, this medical trial is open for recruitment and has been since April 9th 2021. Its last update was February 25th 2022 and a total of 30 patients are needed from one single location."

Answered by AI

What medical maladies is Ropivacaine 0.2% Injectable Solution typically utilized to address?

"Ropivacaine 0.2% Injectable Solution is a common anaesthetic medication typically used during surgical procedures and childbirth or to manage postoperative pain."

Answered by AI

Are new participants being accepted at this point for the experiment?

"This is accurate; clinicaltrials.gov has reported that the trial, which was initially published on April 9th 2021, is actively recruiting to fill 30 vacancies across a solitary site of recruitment."

Answered by AI

How hazardous is Ropivacaine 0.2% Injectable Solution to patients' wellbeing?

"There is an abundance of evidence supporting the safety of Ropivacaine 0.2% Injectable Solution, thus it's been awarded a 3 on our rating scale due to its Phase 4 status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery

2021. "Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04472299.

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