Stellate Ganglion to Prevent Atrial Fibrillation

NCT05656170 | Withdrawn

• 1 other identifier: 21022602
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

New onset atrial fibrillation is a common problem after cardiac surgery. The reported incidence after coronary artery bypass grafting (CABG) is 15-40%, 37-50% after valve surgery, and up to 60% after CABG and valve surgery. Post-operative atrial fibrillation (POAF) is associated with increase risk for stroke, increased length of hospital stay, increase risk of other new arrhythmias, increased need for pacemaker implantation, and increased mortality. Several interventions have been implemented in order to prevent post-operative atrial fibrillation including use of betablockers, sotalol, amiodarone, atrial pacing, and antioxidant vitamins. Despite these interventions (several carry risk of adverse effects) POAF remains common. Cardiac sympathetic innervation arises from the stellate ganglion. Stellate ganglion block (SGB) with local anesthetic agents (lidocaine or bupivacaine) can reduce sympathetic output to the heart with minimal side effects. This procedure has been successfully utilized in patients with medication refractory ventricular arrhythmias. In atrial tissue SGB has been shown to prolong atrial effective refractory periods, reduce atrial arrhythmia inducibility, and shorten atrial fibrillation duration in patients who have atrial fibrillation. Pre-operative SGB has been utilized to prevent post-operative radial artery spasm (when the radial artery was used a coronary bypass graft conduit). The investigators hypothesize that pre-operative SGB will reduce the incidence of post-operative new atrial fibrillation in patients undergoing cardiac surgery.

Conditions

Atrial Fibrillation New Onset

Keywords

post-operative arrhythmias; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of new onset atrial fibrillation after CABG surgery

  Atrial fibrillation will be identified by Continuous cardiac rhythm monitoring (telemetry) throughout the post operative period

  from surgery completion to discharge, up to 1 month

Secondary Outcomes (2)

• Duration of atrial fibrillation

  from surgery completion to discharge, up to 1 month

• Incidence of any other arrhythmias (such as atrial flutter, atrial tachycardia, premature ventricular contractions, or ventricular tachycardia)

  from surgery completion to discharge, up to 1 month

Study Arms (2)

Stellate ganglion block arm

EXPERIMENTAL

This arm will receive a one time bilateral stellate ganglion block with 20 cc bupivacaine (10 cc per side).

Procedure: Stellate ganglion block; Drug: Bupivacain

Placebo arm

SHAM COMPARATOR

This arm will receive a one time bilateral injection with 20 cc normal saline(10 cc per side).

Procedure: Stellate ganglion block; Drug: Saline

Interventions

Stellate ganglion block PROCEDURE

Ultrasound will be utilized to identify anatomic landmarks and prepare for the stellate ganglion block. Skin will be prepped with chloraprep. The C6 level is identified. The Chassaignac tubercle (the anterior tubercle of the C6 vertebral body) is then identified. Placement of the ultrasound transducer helps retract the carotid sheath and sternocleidomastoid muscle laterally. Pressure is applied with the ultrasound transducer to reduce the distance between the skin and tubercle. The needle is inserted towards to the Chassaignac tubercle after contact it is redirected towards the body of C6. The needle is then withdrawn 1-2 mm to bring it out of the longus colli muscle while still staying within the prevertebral fascia. After negative aspiration, 1-2 mL of local anesthetic (or normal saline in the placebo group) is injected, and spread can be visualized with ultrasound. Once confirming that the injection was subfascial, the remaining local anesthetic can be given (10 mL in total).

Placebo arm; Stellate ganglion block arm

Bupivacain DRUG

The intervention group will receive bupivacaine injection guided by ultrasound at the location of the stellate ganglion.

Stellate ganglion block arm

Saline DRUG

The control group will receive a normal saline injection guided by ultrasound at the location of the stellate ganglion.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old scheduled to undergo elective coronary artery bypass (CABG) surgery based on current surgical guidelines.

You may not qualify if:

• Prior history of atrial fibrillation
• Current antiarrhythmic use (other than beta blockers)
• Inability of patient to provide consent for themselves either due to medical or psychiatric comorbidity
• Non-elective surgery
• Patients undergoing mitral valve replacement or repair surgery
• Patients undergoing surgical MAZE procedure
• Pregnancy
• History of neck surgery
• Systemic or local infection
• Current coagulopathy
• Pathologic bradycardia (baseline heart rate \<50 beats/minute or untreated atrioventricular block)
• History of glaucoma
• Allergy to lidocaine

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (17)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Timothy R Larsen, DO

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective placebo controlled clinical trial

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: December 19, 2022
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share