A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-19

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stellate ganglion block with local anesthetic

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

Group Type EXPERIMENTAL

Stellate ganglion block

Intervention Type PROCEDURE

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

Bupivacaine

Intervention Type DRUG

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

Stellate ganglion block with saline placebo

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

Group Type SHAM_COMPARATOR

Stellate ganglion block

Intervention Type PROCEDURE

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

Placebo

Intervention Type DRUG

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

Interventions

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Stellate ganglion block

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

Intervention Type PROCEDURE

Bupivacaine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No