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

University of Minnesota (UMN) logo

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)

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.

Trial contacts and locations

1

Loading...

Central trial contact

Candace Nelson

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems