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

Primary Purpose

New Onset Atrial Fibrillation, Anesthesia, Local, Cardiac Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for New Onset Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Participants in this group will receive the intervention.

Participants in this group will receive no intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cumulative Opioid Use - Average Dosages
Outcome reported as the average opioid dosage at 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.
Time to Extubation
Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.
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.
Hospital Length of Stay
Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.
30-Day Mortality
Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.
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.
Diagnosis of delirium during index hospitalization
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
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
Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).
Block-associated complications
Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.
Block performance time
Outcome reported as the length of time (in minutes) for placement of catheters.
Duration of vasopressor requirement
Outcome reported as the length of time (in hours) that participants require vasopressor therapy.

Full Information

First Posted
July 9, 2020
Last Updated
October 3, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04472299
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
New Onset Atrial Fibrillation, Anesthesia, Local, Cardiac Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Participants in this group will receive the intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group will receive no intervention.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of New-Onset Atrial Fibrillation (NOAF)
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Cumulative Opioid Use - Average Dosages
Description
Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.
Time Frame
24, 48, 72, 96, and 120 hours post-operatively
Title
Cumulative Opioid Use - Morphine Equivalents
Description
Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.
Time Frame
24, 48, 72, 96, and 120 hours post-operatively
Title
Time to Extubation
Description
Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.
Time Frame
approximately 5 days
Title
Intensive Care Unit (ICU) Length of Stay
Description
Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.
Time Frame
approximately 5 days
Title
Hospital Length of Stay
Description
Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.
Time Frame
approximately 7 days
Title
30-Day Mortality
Description
Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.
Time Frame
30 days
Title
Cumulative ICU sedation doses
Description
Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.
Time Frame
24 and 72 hours post-operatively
Title
Diagnosis of delirium during index hospitalization
Description
Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.
Time Frame
approximately 7 days
Title
Quality of Recovery 15 (QOR-15) Scores
Description
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.
Time Frame
24, 48, 72, 96, and 120 hours post-operatively
Title
Average pain score
Description
Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).
Time Frame
24, 48, 72, 96, and 120 hours post-operatively
Title
Block-associated complications
Description
Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.
Time Frame
approximately 5 days
Title
Block performance time
Description
Outcome reported as the length of time (in minutes) for placement of catheters.
Time Frame
approximately 1 hour
Title
Duration of vasopressor requirement
Description
Outcome reported as the length of time (in hours) that participants require vasopressor therapy.
Time Frame
approximately 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candace Nelson
Phone
612-626-2465
Email
nelso377@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Flaherty, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonah Pearson, MD
Phone
218-280-8348
Email
jonahmpearson@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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