Actively Recruiting

Phase 2
Phase 3
Age: 60Years +
All Genders
ID05357690

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

Led by Mayo Clinic · Updated on 2026-06-03

220

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a nerve block procedure called stellate ganglion block can reduce the chance of atrial fibrillation after heart surgery. Atrial fibrillation is an abnormal, fast heartbeat in the upper chambers of the heart. The study aims to see if blocking the stellate ganglion with a local anesthetic before surgery can lower how often and how long atrial fibrillation occurs after the operation. Participants are randomly assigned to receive either a single injection of bupivacaine, a local anesthetic, or a saline placebo into the stellate ganglion on the right side of the neck before cardiac surgery. This procedure is guided by ultrasound and done in a sterile manner. The study compares the effects of the anesthetic versus placebo on the incidence and duration of atrial fibrillation within one week after surgery or during the hospital stay if discharged earlier. During the study, researchers will monitor the occurrence and length of atrial fibrillation after surgery. They will also assess the success of the nerve block by measuring changes in hand temperature and skin sympathetic nerve activity shortly after the procedure. Participants will be followed for up to one week post-surgery or until hospital discharge, with close observation to collect these measurements and evaluate any effects of the nerve block.

CONDITIONS

Brief Title

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Age 60 years or older.
Not Eligible

You will not qualify if you...

  • History of permanent atrial fibrillation.
  • Left or right ventricular assist device implantation or explantation.
  • Procedures not requiring cardiopulmonary bypass.
  • Procedures requiring deep hypothermic circulatory arrest.
  • Active infection or sepsis.
  • Pre-operative immunosuppressive medication use including steroids.
  • Pre-operative anti-arrhythmic medication use aside from beta-blockers.
  • Immunodeficiency syndrome.
  • Known neurologic disorder.
  • Requirement for left internal jugular central line placement.
  • Maze procedures or left atrial appendage ligation do not exclude participation as atrial fibrillation may still occur postoperatively while scarring forms.
  • Age below 60 years old is excluded implicitly by minimum age requirement (added for clarity).

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive a single stellate ganglion block injection with either local anesthetic or saline placebo prior to cardiac surgery.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - Up to 1 week

Participants are monitored for atrial fibrillation incidence and duration within one week of surgery or during hospitalization if discharged prior to one week.

Daily assessments during hospital stay or up to one week

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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