Nerve Block for Heart Rhythm Problems

Overseen By Timothy Markman, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Hemodynamic instability, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called stellate ganglion block, which aims to help individuals with ventricular tachycardia, a type of fast heart rhythm. The researchers are examining how this treatment might affect heart rhythm and certain body chemicals during a VT ablation procedure. This study may suit those planning to undergo catheter-based VT ablation and without known allergies to specific local anesthetics. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the stellate ganglion block is safe for patients with ventricular tachycardia?

Research has shown that stellate ganglion block (SGB) is generally safe for people with heart rhythm issues. Studies have found it to be a safe option for treating severe irregular heartbeats. One study found that SGB reduced the need for electrical shocks to correct these heart problems.

Although SGB appears safe, more research is needed to confirm its safety in various situations. Early trials are currently testing this treatment, so much remains to be learned about its safety. However, current research appears promising for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Stellate Ganglion Block for heart rhythm problems because it offers a unique approach by directly targeting the nerves involved in the heart's rhythm regulation. Unlike standard treatments like antiarrhythmic drugs or catheter ablation, which focus on modifying the heart tissue or electrical signals, the Stellate Ganglion Block aims to modulate the nervous system's influence on the heart. This nerve block could potentially provide quicker relief and reduce the recurrence of arrhythmias by calming the sympathetic nerve activity, which is often heightened in these conditions.

What evidence suggests that the stellate ganglion block is effective for heart rhythm problems?

Research has shown that a treatment called stellate ganglion block (SGB), which participants in this trial will receive, can help with irregular heartbeats, known as ventricular arrhythmias. In one study, 92% of people experienced fewer symptoms after receiving SGB. It is also considered a safe and effective emergency treatment for serious heart rhythm issues. Observations suggest that SGB can reduce episodes of these irregular heartbeats. However, further research is needed to confirm these results. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults at least 18 years old who are scheduled to have a catheter-based procedure to correct rapid, irregular heartbeats known as ventricular tachycardia. Pregnant individuals, those with conditions that make the stellate ganglion block or VT ablation unsafe, and people allergic to certain local anesthetics cannot participate.

Inclusion Criteria

I am scheduled for a procedure to treat irregular heartbeats using catheters.

Exclusion Criteria

I cannot undergo SGB or VT ablation due to health reasons.

You had unstable blood pressure or heart rate during a medical procedure before the study.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo stellate ganglion block during their VT ablation procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ventricular effective refractory period and neuropeptide Y levels

30 minutes

What Are the Treatments Tested in This Trial?

Interventions

• Stellate Ganglion Block

Trial Overview The study is examining how a nerve-blocking injection called Stellate Ganglion Block (SGB) affects the electrical activity of the heart in patients with ventricular tachycardia. It's a forward-looking study tracking participants over time.

How Is the Trial Designed?

Group I: Stellate ganglion block Experimental Treatment 1 Intervention

All subjects will undergo stellate ganglion block during their VT ablation procedure

Stellate Ganglion Block is already approved in United States for the following indications:

Approved in United States as Stellate Ganglion Block for:

• Chronic pain management
• Posttraumatic stress disorder (PTSD) symptoms reduction

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Stellate ganglion block (SGB) has been found effective for non-pain indications such as reducing cardiovascular sympathetic stimulation and improving blood flow in limbs, with moderate to low certainty based on 24 studies including 19 randomized controlled trials.

SGB is also recommended for alleviating menopausal symptoms like hot flashes, particularly in cases where conventional treatments have failed, although evidence for other non-pain uses remains insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block for non-pain indications: a scoping review. Feigin, G., Velasco Figueroa, S., Englesakis, MF., et al.[2023]

In a study of 30 patients with drug-refractory electrical storm, percutaneous stellate ganglion blockade (SGB) successfully controlled ventricular arrhythmias (VA) in 60% of patients within 24 hours, significantly reducing hospital mortality rates for those whose VA was managed (5.6% vs. 50.0%).

SGB led to a remarkable 92% reduction in VA episodes in the 72 hours following the procedure, demonstrating its efficacy as a treatment option for patients who have not responded to other therapies, with no major complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Tian, Y., Wittwer, ED., Kapa, S., et al.[2020]

Stellate ganglion blockade (SGB) can significantly reduce the frequency of refractory ventricular arrhythmias for 24-72 hours, providing a critical window for other treatments like catheter ablation or heart transplantation.

SGB is a safe procedure with a low risk of complications, even in patients on anticoagulation, making it a viable option for managing various types of ventricular arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Blockade: an Intervention for the Management of Ventricular Arrhythmias. Ganesh, A., Qadri, YJ., Boortz-Marx, RL., et al.[2021]

This clinical trial aims to evaluate whether a single-shot stellate ganglion block (SGB) can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) in high-risk patients undergoing laparoscopic colorectal cancer surgery, involving 950 participants aged over 45 with at least one risk factor for MINS.

The study will assess multiple outcomes, including pain levels, recovery quality, and serious cardiovascular complications, providing a comprehensive evaluation of SGB's efficacy and safety in improving postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial. Hu, Z., Li, W., Zhao, G., et al.[2023]

In a study of 60 patients with complex regional pain syndrome type II undergoing surgery, stellate ganglion block (SGB) significantly reduced the need for intraoperative propofol and fentanyl, indicating its efficacy in managing acute pain during surgery.

Patients receiving SGB also experienced a longer time before needing their first analgesic and required less fentanyl in the 24 hours post-surgery, suggesting that SGB can effectively decrease opioid consumption after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block on Intraoperative Propofol and Fentanyl Consumption in Patients with Complex Regional Pain Syndrome Undergoing Surgical Repair of Brachial Plexus Injury: A Randomized, Double-blind, Placebo-controlled Trial. Rajagopalan, V., Chouhan, RS., Pandia, MP., et al.[2022]

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/PMC10919926/

Stellate ganglion blockade for the management of ventricular ... The principal finding of this study was that 92% (106/115) of the enrolled participants met the primary outcome (50% reduction of ATP or shocks ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X24000082

A Multicenter Study of Stellate Ganglion Block as ... Stellate ganglion blockade (SGB) has been described as an adjunct, temporizing intervention in patients with refractory ventricular arrhythmia.

3. nature.com nature.com/articles/s41598-024-76663-9

Efficacy of stellate ganglion block in treatment of electrical ... In conclusion, observational data suggests SGB may be effective in reducing VAs in ES. Definitive studies for SGB in VA management are needed.

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02051-X/fulltext

PO-07-070 STELLATE GANGLION BLOCK IN THE ... SGB is a safe, effective emergent therapy for life threatening ventricular arrhythmias, needing validation through prospective studies.

5. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.13790

Abstract 13790: Efficacy of Stellate Ganglion Block for ... Of the reported patients, 75.4% of patients survived throughout the hospital course. Conclusion: SGB significantly reduced VAs episodes in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40569055/

Stellate Ganglion Block for Recurrent Ventricular Arrhythmias This study reviews current evidence on its mechanisms, patient selection, and clinical outcomes to guide future research.

7. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2024/02/20/03/01/a-multicenter-study-of-stellate

Stellate Ganglion Block for Refractory Ventricular Arrhythmias In a registry study, SGB use was associated with a reduction in the burden of ventricular arrhythmia and the need for electrical cardioversion.