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OpenTrials
Completed

NCT Number: NCT05357690

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stellate ganglion block

Procedure

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

Bupivacaine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Incidence of atrial fibrillation

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

    Percentage of subjects to experience postoperative atrial fibrillation (POAF)

Secondary outcomes

  1. Duration of atrial fibrillation

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

    Duration of postoperative atrial fibrillation (POAF)

  2. Skin Sympathetic Nerve Activity

    Time frame: 10-30 minute following performance of nerve block

    Measurement of difference in skin sympathetic nerve activity following block

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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