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

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 4

Conditions: New Onset Atrial Fibrillation; Anesthesia, Local; Cardiac Disease

Treatments: Drug: Ropivacaine 0.2% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04472299

ANES-2020-28859

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental

Experimental group

Description:

Participants in this group will receive the intervention.

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Control

No Intervention group

Description:

Participants in this group will receive no intervention.