Clinical trial NCT04472299: Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery
Official title: Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: New Onset Atrial Fibrillation
Anesthesia, Local
Cardiac Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of New-Onset Atrial Fibrillation (NOAF)
timeFrame: 5 days
Secondary outcomes:
measure: Cumulative Opioid Use - Average Dosages
timeFrame: 24, 48, 72, 96, and 120 hours post-operatively
measure: Cumulative Opioid Use - Morphine Equivalents
timeFrame: 24, 48, 72, 96, and 120 hours post-operatively
measure: Time to Extubation
timeFrame: approximately 5 days
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: approximately 5 days
measure: Hospital Length of Stay
timeFrame: approximately 7 days
measure: 30-Day Mortality
timeFrame: 30 days
measure: Cumulative ICU sedation doses
timeFrame: 24 and 72 hours post-operatively
measure: Diagnosis of delirium during index hospitalization
timeFrame: approximately 7 days
measure: Quality of Recovery 15 (QOR-15) Scores
timeFrame: 24, 48, 72, 96, and 120 hours post-operatively
measure: Average pain score
timeFrame: 24, 48, 72, 96, and 120 hours post-operatively
measure: Block-associated complications
timeFrame: approximately 5 days
measure: Block performance time
timeFrame: approximately 1 hour
measure: Duration of vasopressor requirement
timeFrame: approximately 24 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: James Flaherty, MD
role: PRINCIPAL_INVESTIGATOR
References: