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CompletedNCT05357690Updated Jul 10, 2026

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

A Phase 2/3 interventional study of Stellate ganglion block and Bupivacaine in Atrial Fibrillation, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed 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).

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 200 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Stellate ganglion block with local anesthetic

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

    Procedure: Stellate ganglion block · Drug: Bupivacaine

  • Sham comparator
    Stellate ganglion block with saline placebo

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

    Procedure: Stellate ganglion block · Drug: Placebo

Interventions

  • ProcedureStellate ganglion block

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

  • DrugBupivacaine

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Incidence of atrial fibrillation

    Percentage of subjects to experience postoperative atrial fibrillation (POAF)

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

Secondary outcomes

  1. Duration of atrial fibrillation

    Duration of postoperative atrial fibrillation (POAF)

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

  2. Skin Sympathetic Nerve Activity

    Measurement of difference in skin sympathetic nerve activity following block

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

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05357690
Lead sponsor
Mayo Clinic
Responsible party
Erica D. Wittwer, M.D., Ph.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 3, 2022
Start date
Apr 19, 2023
Primary completion
Jun 8, 2026
Completion
Jun 8, 2026
Last update
Jul 10, 2026

Study contacts

Erica Wittwer, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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