Stellate Ganglion to Prevent Atrial Fibrillation

NCT05656170 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-28

No results posted yet for this study

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

Interventions

PROCEDURE

Stellate ganglion block

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 The needle is then withdrawn 1-2 mm to bring it out of the longus colli muscle while still staying within the prevertebral fascia.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).

DRUG

Bupivacain

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

DRUG

Saline

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Timothy R Larsen, DO · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-04-30
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656170 on ClinicalTrials.gov