A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357690
• Other study ID #: 22-001106
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Stellate ganglion block
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.

Drug:
• Bupivacaine
10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion
• Placebo
10 mL of saline injected in the plane of the right stellate ganglion

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of atrial fibrillation	Percentage of subjects to experience postoperative atrial fibrillation (POAF)	Within one week of surgery or during hospitalization if discharged prior to one week
Secondary	Duration of atrial fibrillation	Duration of postoperative atrial fibrillation (POAF)	Within one week of surgery or during hospitalization if discharged prior to one week
Secondary	Skin Sympathetic Nerve Activity	Measurement of difference in skin sympathetic nerve activity following block	10-30 minute following performance of nerve block

External Links

•   Mayo Clinic Clinical Trials