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

Phase 4

Recruiting

• Conditions: New Onset Atrial Fibrillation; Anesthesia, Local; Cardiac Disease
• Interventions: Drug: Ropivacaine 0.2% Injectable Solution

• Registration Number: NCT04472299
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2021-04-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Ropivacaine 0.2% Injectable Solution	Participants in this group will receive the intervention.

Primary Outcome Measures

Name	Time	Method
Incidence of New-Onset Atrial Fibrillation (NOAF)	5 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States