A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Mayo Clinic

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Atrial Fibrillation

Treatments: Procedure: Stellate ganglion block; Drug: Placebo; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05357690

22-001106

Details and patient eligibility

About

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.

Full 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).

Enrollment: 220 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

Stellate ganglion block with local anesthetic

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Procedure: Stellate ganglion block

Stellate ganglion block with saline placebo

Sham Comparator group

Description:

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

Treatment:

Drug: Placebo

Procedure: Stellate ganglion block