Stellate Ganglion Block for Postural Orthostatic Tachycardia Syndrome

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called stellate ganglion block (SGB) to help manage symptoms of Postural Orthostatic Tachycardia Syndrome (POTS). POTS causes the heart to race and can lead to dizziness or fainting when standing. The study will compare the effects of SGB, which involves an injection in the neck area to block certain nerves, against a placebo treatment to determine its effectiveness in controlling these symptoms. Individuals with POTS who can attend follow-up visits might be suitable candidates for this study. As an unphased trial, this study offers the opportunity to contribute to valuable research that could enhance future treatment options for POTS.

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 prior data suggests that the stellate ganglion block is safe for treating Postural Orthostatic Tachycardia Syndrome?

Research shows that stellate ganglion block (SGB) is generally safe, though rare complications can occur. Some studies have mentioned serious issues like retropharyngeal hematomas, which are bruises in the throat, but these remain uncommon. Many patients have undergone SGB without major problems.

One study used SGB to help people with Long COVID symptoms and showed positive results without significant side effects. Another study noted a decrease in heart rate after the procedure, but no major changes in blood pressure or other heart-related measures.

Overall, while SGB carries some risks, patients usually tolerate it well. Always consult your doctor about potential side effects before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Postural Orthostatic Tachycardia Syndrome (POTS), which include lifestyle changes, medications like beta-blockers, and increased fluid and salt intake, the Stellate Ganglion Block (SGB) offers a novel approach by targeting the sympathetic nervous system directly. SGB involves an ultrasound-guided injection of ropivacaine, which is thought to block nerve signals that can contribute to symptoms of POTS. Researchers are excited about SGB because it could provide rapid relief of symptoms and potentially offer a more targeted solution with fewer systemic side effects compared to oral medications.

What evidence suggests that stellate ganglion block might be an effective treatment for POTS?

Research has shown that a treatment called stellate ganglion block (SGB), which participants in this trial may receive, can help people with Postural Orthostatic Tachycardia Syndrome (POTS). Studies have found that SGB can lower heart rate, benefiting POTS patients who often experience rapid heartbeats upon standing. SGB also calms the nervous system, potentially reducing heart rhythm problems and fainting spells common in POTS. In one study, 94% of patients with moderate-to-severe nervous system issues reported improvement after receiving SGB. This suggests that SGB could be a promising way to manage POTS symptoms. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11385263/

The Effectiveness and Safety of Stellate Ganglion Block in ... Results. A total of 94% of patients reported moderate-to-severe autonomic dysfunction pre-procedure as measured by COMPASS-31. All patients reported ...

2. painmedicine-casereports.com painmedicine-casereports.com/current/pdf?article=ODI5

USE OF STELLATE GANGLION BLOCK IN THE ... For a POTS diagnosis, patients must experience symptoms of orthostatic intolerance for at least 6 months, with exclusion of other conditions ...

3. withpower.com withpower.com/trial/phase-postural-orthostatic-tachycardia-syndrome-6-2025-981f9

Stellate Ganglion Block for Postural Orthostatic ... 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 ...

4. nwregen.com nwregen.com/articles/how-stellate-ganglion-block-treats-pots-symptoms-2/

How Stellate Ganglion Block Treats POTS Symptoms Studies have shown that SGB can lead to a significant reduction in heart rate, which is particularly beneficial for POTS patients who experience ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165572821003118

Stellate ganglion block reduces symptoms of Long COVID Stellate ganglion block increases cerebral blood flow and alleviates Long COVID symptoms. •. The interaction between nervous and immune systems ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6973270/

Stellate ganglion block and cardiac sympathetic denervation ... Left SG block reduced HR from 99 (21) to 87(16) bpm (P = .02) at 60 minutes. SG block had no significant effect on blood pressure or HR response to ...