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

NCT04472299 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: ANES-2020-28859
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

Conditions

New Onset Atrial Fibrillation; Anesthesia, Local; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of New-Onset Atrial Fibrillation (NOAF)

  The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.

  5 days

Secondary Outcomes (13)

• Cumulative Opioid Use - Average Dosages

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

• Cumulative Opioid Use - Morphine Equivalents

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

• Time to Extubation

  approximately 5 days

• Intensive Care Unit (ICU) Length of Stay

  approximately 5 days

• Hospital Length of Stay

  approximately 7 days

Study Arms (2)

Experimental

EXPERIMENTAL

Participants in this group will receive the intervention.

Drug: Ropivacaine 0.2% Injectable Solution

Control

NO INTERVENTION

Participants in this group will receive no intervention.

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• History of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) \< 30%
• Emergency surgery
• Redo surgery
• Contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic)
• Body mass index \> 35kg/m2
• Pregnancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• James Flaherty, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: April 9, 2021
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)