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

NCT ID: NCT04472299

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2025-07-08

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.

Detailed Description

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. Patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.

Conditions

New Onset Atrial Fibrillation; Anesthesia, Local; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental

Participants in this group will receive the intervention.

Group Type: EXPERIMENTAL

Ropivacaine 0.2% Injectable Solution

Intervention Type: 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.

Control

Participants in this group will receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine 0.2% Injectable Solution

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Flaherty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

ANES-2020-28859

Identifier Type: -

Identifier Source: org_study_id