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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472299
• Other study ID #: ANES-2020-28859
• Status: Recruiting
• Phase: Phase 4
• Start date: April 9, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: Candace Nelson
• Phone: 612-626-2465
• Email: nelso377[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Atrial Fibrillation
• Cardiac Disease
• Heart Diseases
• New Onset Atrial Fibrillation

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time to Extubation	Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.	approximately 5 days
Secondary	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
Secondary	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
Secondary	30-Day Mortality	Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Block performance time	Outcome reported as the length of time (in minutes) for placement of catheters.	approximately 1 hour
Secondary	Duration of vasopressor requirement	Outcome reported as the length of time (in hours) that participants require vasopressor therapy.	approximately 24 hours