Stellate Ganglion Block for Postural Orthostatic Tachycardia Syndrome

Recruiting at 1 trial location

Overseen By Anna Maria Bombardieri, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cardiac arrhythmia, Heart failure, Myocarditis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you maintain a stable medication regimen throughout the study.

What data supports the effectiveness of the treatment Stellate Ganglion Block for Postural Orthostatic Tachycardia Syndrome?

Stellate Ganglion Block has been shown to help with heart rhythm problems and fainting spells by calming the nervous system, which might suggest it could help with Postural Orthostatic Tachycardia Syndrome, a condition involving abnormal heart rate and blood pressure regulation. ^{1 2 3 4 5}

Is Stellate Ganglion Block generally safe for humans?

Stellate Ganglion Block is generally considered safe, but in rare cases, it can cause serious complications like retropharyngeal hematomas (a type of throat bleeding) and toxicity from the anesthetics used. Convulsions can also occur if the anesthetic is accidentally injected into an artery. ^{2 6 7 8 9}

How does the stellate ganglion block treatment differ from other treatments for Postural Orthostatic Tachycardia Syndrome?

Stellate ganglion block (SGB) is unique because it targets the sympathetic nervous system, which can help stabilize heart rate and blood pressure by interrupting nerve signals. Unlike typical medications, SGB is a nerve block procedure that can provide rapid relief and is often used when other treatments are ineffective. ^{1 2 3 10 11}

What is the purpose of this trial?

This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.

Eligibility Criteria

This trial is for individuals with Postural Tachycardia Syndrome (POTS), which causes rapid heartbeat and other symptoms when standing. Participants should be thoroughly diagnosed with POTS but the specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Ability to provide informed consent

Ability to comply with 3 follow up visits

I am over 18 and have been diagnosed with POTS.

Exclusion Criteria

Allergy to local anesthetics

I have a severe blood clotting disorder.

I have a serious heart or lung condition that could affect my study participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either an ultrasound guided stellate ganglion block with ropivacaine or a sham saline injection

1 day

1 visit (in-person)

Immediate Post-Treatment Assessment

Assessment of Horner's syndrome, facial skin temperature, and facial sweating to measure immediate effects of the procedure

Within 10 minutes after the procedure

1 visit (in-person)

Follow-up

Participants are monitored for changes in autonomic symptoms, heart rate variability, and other health metrics

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Stellate Ganglion Block

Trial Overview The study tests a procedure called stellate ganglion block (SGB) using Ropivacaine, compared to a sham injection of saline. The goal is to see if SGB can help manage POTS symptoms both immediately after treatment and in the long term.

Participant Groups

Group I: Intervention Group (stellate ganglion block) Experimental Treatment 2 Interventions

Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine.

Group II: Control Group (sham injection with saline) Placebo Group 2 Interventions

Patients will receive a subcutaneous sham injection with saline. Ultrasound imaging will be used to simulate the guidance process as in the active procedure, maintaining consistency in the procedural experience.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

A 59-year-old male with refractory ventricular tachycardia (VT) experienced immediate cessation of VT and maintained sinus rhythm after receiving a left stellate ganglion block (LSGB) using a lidocaine and bupivacaine solution.

The LSGB procedure appears to be a safe and effective method for controlling refractory VT, suggesting its potential as a rescue therapy before more invasive treatments like catheter ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. Yang, SC., Wu, CC., Hsieh, YJ.[2022]

Stellate ganglion block (SGB) is generally a safe procedure, but it can lead to serious complications like retropharyngeal hematomas (RPH) and local anesthetic toxicity in rare cases.

Management of these complications includes emergency airway management for RPH and the use of higher doses of intravenous lipid emulsions to improve outcomes in cases of local anesthetic toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complication and Anesthetics-induced Toxicity of Stellate Ganglion Block]. Okuda, Y., Suzuki, H., Saima, S.[2018]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Treatment of a patient with refractory cardiac arrhythmias using stellate ganglion block. Access by the classical and ultrasound-guided approach]. [2017]

2. Japan pubmed.ncbi.nlm.nih.gov

A case of successful percutaneous ethanol stellate ganglion block on ventricular tachycardia storm. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Use of stellate ganglion block for treatment of recurrent syncope followed by chest pain. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Effects of bilateral stellate ganglion block on autonomic cardiovascular regulation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Aetiology of convulsions due to stellate ganglion block: a review and report of two cases. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Complication and Anesthetics-induced Toxicity of Stellate Ganglion Block]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Preeminence of the left stellate ganglion in the long Q-T syndrome. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Sympathetically induced atrial tachycardia. Successful treatment by left stellate ganglion block. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Anterior cervical approach for stellate ganglion and T2 to T3 sympathetic blocks: a novel technique. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Electrophysiologic effects of unilateral right and left stellate ganglion block on the human heart. [2019]