A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2025 by Mayo Clinic
Sponsor
Mayo Clinic
Information Provided by (Responsible Party)
Erica D. Wittwer, M.D., Ph.D.
Clinicaltrials.gov Identifier
NCT05357690
Other Study ID Numbers:
22-001106
First Submitted
April 26, 2022
First Posted
May 2, 2022
Last Update Posted
May 13, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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).

Condition or DiseaseIntervention/Treatment
Atrial Fibrillation
Procedure: Stellate ganglion blockProcedure: Stellate ganglion block

Study Design

Study TypeInterventional
Actual Enrollment220 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleStellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial
Study Start DateApril 18, 2023
Actual Primary Completion DateMarch 31, 2026
Actual Study Completion Date6mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Stellate ganglion block with local anesthetic
Subjects will receive a single injection of bupivacaine in a stellate ganglion block
Procedure: Stellate ganglion block
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.
Stellate ganglion block with saline placebo
Subjects will receive a single injection of saline in a stellate ganglion block
Procedure: Stellate ganglion block
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.

Outcome Measures

Primary Outcome Measures
  1. Incidence of atrial fibrillation
    Percentage of subjects to experience postoperative atrial fibrillation (POAF)
Secondary Outcome Measures
  1. Duration of atrial fibrillation
    Duration of postoperative atrial fibrillation (POAF)
  2. Skin Sympathetic Nerve Activity
    Measurement of difference in skin sympathetic nerve activity following block

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsMayo Clinic
Locations
Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905
Investigators
Principal Investigator: Erica Wittwer, MD, Mayo Clinic