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A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stellate ganglion block

Bupivacaine

Placebo

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.

Exclusion Criteria:

Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.
Patients with procedures not requiring cardiopulmonary bypass.
Patients with procedures requiring deep hypothermic circulatory arrest.
Patients with active infection or sepsis.
Pre-operative immunosuppressive medication use (including steroid use).
Pre-operative anti-arrhythmic medication use (aside from beta-blockers).
Patients with Immunodeficiency syndrome.
Patients with known neurologic disorder.
Patients requiring left internal jugular central line placement.
Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stellate ganglion block with local anesthetic

Stellate ganglion block with saline placebo

Arm Description

Subjects will receive a single injection of bupivacaine in a stellate ganglion block

Subjects will receive a single injection of saline in a stellate ganglion block

Outcomes

Primary Outcome Measures

Incidence of atrial fibrillation

Percentage of subjects to experience postoperative atrial fibrillation (POAF)

Secondary Outcome Measures

Duration of atrial fibrillation

Duration of postoperative atrial fibrillation (POAF)

Skin Sympathetic Nerve Activity

Measurement of difference in skin sympathetic nerve activity following block

Full Information

NCT ID

NCT05357690

First Posted

April 27, 2022

Last Updated

May 8, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05357690

Brief Title

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Official Title

Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.

Detailed Description

The investigator hypothesizes that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (POAF). Specific Aim 1: Determine the incidence of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week. Specific Aim 2: Determine the duration of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week. Specific Aim 3: Determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (SKNA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stellate ganglion block with local anesthetic

Arm Type

Experimental

Arm Description

Subjects will receive a single injection of bupivacaine in a stellate ganglion block

Arm Title

Stellate ganglion block with saline placebo

Arm Type

Sham Comparator

Arm Description

Subjects will receive a single injection of saline in a stellate ganglion block

Intervention Type

Procedure

Intervention Name(s)

Stellate ganglion block

Intervention Description

Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

10 mL of saline injected in the plane of the right stellate ganglion

Primary Outcome Measure Information:

Title

Incidence of atrial fibrillation

Description

Percentage of subjects to experience postoperative atrial fibrillation (POAF)

Time Frame

Within one week of surgery or during hospitalization if discharged prior to one week

Secondary Outcome Measure Information:

Title

Duration of atrial fibrillation

Description

Duration of postoperative atrial fibrillation (POAF)

Time Frame

Within one week of surgery or during hospitalization if discharged prior to one week

Title

Skin Sympathetic Nerve Activity

Description

Measurement of difference in skin sympathetic nerve activity following block

Time Frame

10-30 minute following performance of nerve block

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota. Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting. Exclusion Criteria: Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation. Patients with procedures not requiring cardiopulmonary bypass. Patients with procedures requiring deep hypothermic circulatory arrest. Patients with active infection or sepsis. Pre-operative immunosuppressive medication use (including steroid use). Pre-operative anti-arrhythmic medication use (aside from beta-blockers). Patients with Immunodeficiency syndrome. Patients with known neurologic disorder. Patients requiring left internal jugular central line placement. Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erica Wittwer, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erica Wittwer, MD

Phone

507-255-9814

Wittwer.Erica@mayo.edu

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

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