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

Trial Summary

What is the purpose of this trial?

Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.

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.

Is Stellate Ganglion Block generally safe for humans?

Stellate Ganglion Block (SGB) is generally considered a safe procedure, but in rare cases, it can lead to serious complications like retropharyngeal hematomas (a type of throat bleeding) and toxicity from anesthetics. These complications require careful management, and preventive measures are available. ^{1 2 3 4 5}

How is the Stellate Ganglion Block treatment different from other treatments for heart rhythm problems?

Stellate Ganglion Block (SGB) is unique because it blocks sympathetic nerve signals, which can help control heart rhythm problems that don't respond to other treatments. Unlike many standard treatments, SGB is a nerve block procedure rather than a medication or surgery. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Stellate Ganglion Blockade: an Intervention for the Management of Ventricular Arrhythmias. [2021]

2. 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]

3. England 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Stellate ganglion block for non-pain indications: a scoping review. [2023]

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

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

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

Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. [2020]

7. India 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. [2022]