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

Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Cardiac Disease; New Onset Atrial Fibrillation
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants in this group will receive the intervention.	Drug: 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.
No Intervention: Control; Participants in this group will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Use - Average Dosages	Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.	24, 48, 72, 96, and 120 hours post-operatively
Cumulative Opioid Use - Morphine Equivalents	Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.	24, 48, 72, 96, and 120 hours post-operatively
Time to Extubation	Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.	approximately 5 days
Intensive Care Unit (ICU) Length of Stay	Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.	approximately 5 days
Hospital Length of Stay	Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.	approximately 7 days
30-Day Mortality	Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.	30 days
Cumulative ICU sedation doses	Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.	24 and 72 hours post-operatively
Diagnosis of delirium during index hospitalization	Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.	approximately 7 days
Quality of Recovery 15 (QOR-15) Scores	The Quality of Recovery 15 is a 15-item survey evaluating recovery after surgery and anaesthesia. Items are rated on a scale 0-10. Total scores are a sum of item scores and range 0-150, with higher scores representing a higher quality of recovery.	24, 48, 72, 96, and 120 hours post-operatively
Average pain score	Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).	24, 48, 72, 96, and 120 hours post-operatively
Block-associated complications	Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.	approximately 5 days
Block performance time	Outcome reported as the length of time (in minutes) for placement of catheters.	approximately 1 hour
Duration of vasopressor requirement	Outcome reported as the length of time (in hours) that participants require vasopressor therapy.	approximately 24 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: James Flaherty, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Arrhythmias, Cardiac; Heart Diseases; Atrial Fibrillation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: ANES-2020-28859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No