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Study comparing stellate ganglion block with bupivacaine and lidocaine versus amiodarone for patients with electrical storm of the heart

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a condition called electrical storm, which happens when the heart experiences repeated episodes of very fast and dangerous heart rhythms that require treatment with a device called a defibrillator. A defibrillator is a medical device that can deliver electrical shocks to restore normal heart rhythm. This condition can occur in people with various types of heart disease, including problems with the heart arteries or inherited heart rhythm disorders. The study will compare two different treatment approaches for stopping these dangerous heart rhythms.

One treatment being tested is a procedure called percutaneous stellate ganglion block, which involves injecting numbing medications near specific nerves in the neck area that can affect heart rhythm. For this procedure, doctors will use bupivacaine hydrochloride and lidocaine hydrochloride monohydrate, which are medications that temporarily block nerve signals. The other treatment is amiodarone hydrochloride, which is a medication given through a vein that is commonly used to control abnormal heart rhythms and is considered the standard treatment for this condition.

The purpose of this study is to find out if the nerve block procedure works better than amiodarone at completely stopping dangerous heart rhythm episodes in the first three hours after treatment. Participants will be randomly assigned to receive either the nerve block procedure with the numbing medications or the amiodarone medication. Doctors will then monitor how many dangerous heart rhythm episodes occur during the three hours following treatment to determine which approach is more effective at preventing these episodes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    Upon entering the study, you will be randomly assigned to receive one of two treatments for electrical storm, which is a condition where your heart experiences multiple episodes of dangerously fast heart rhythms within a short period of time.

    You will receive either a percutaneous stellate ganglion block, which is a procedure involving an injection near specific nerves in your neck area, or amiodarone, which is a medication given through a vein to control abnormal heart rhythms.

    The assignment to either treatment group will be done randomly, meaning neither you nor your doctor can choose which treatment you receive.

  2. Step 2

    Treatment administration

    If you are assigned to the injection procedure group, you will receive a percutaneous stellate ganglion block. This involves an injection of local anesthetic medication near nerves in your neck. The medications that may be used for this injection include bupivacaine hydrochloride at a concentration of 5 mg per ml or lidocaine hydrochloride at a concentration of 20 mg per ml. These medications work by temporarily blocking nerve signals.

    If you are assigned to the medication group, you will receive amiodarone hydrochloride at a concentration of 50 mg per ml, which will be given through an injection into your vein.

    The treatment you receive is intended to stop the episodes of fast heart rhythms that require treatment from your internal heart device or external defibrillator.

  3. Step 3

    Monitoring during the first three hours

    After receiving your assigned treatment, you will be closely monitored for three hours.

    During this time, your heart rhythm will be observed to determine whether the treatment successfully stops the episodes of fast heart rhythms that would otherwise require treatment with antitachycardia pacing, which is a rapid pacing from your device, or DC shock, which is an electrical shock delivered either by your internal device or an external defibrillator.

    This three-hour period is the primary observation window to assess how well your assigned treatment works to control your heart rhythm.

  4. Step 4

    Continued observation and follow-up

    After the initial three-hour monitoring period, you will continue to be observed as part of the study.

    Your doctors will monitor your heart rhythm and overall condition to assess the longer-term effects of the treatment you received.

    The specific duration and schedule of follow-up visits will be determined by the study protocol.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You must have experienced more than 3 episodes of fast abnormal heart rhythms that were treated by a device inside your body or an external device in the 12 hours before joining the study, with at least one episode occurring in the three hours before joining
  • You must have a fast abnormal heart rhythm that requires treatment with a device that delivers electrical shocks, either from inside or outside your body
  • You must have any type of structural heart disease, which means a physical problem with the structure of your heart
  • You may have acute or chronic coronary disease, which means either a sudden or long-term condition affecting the blood vessels that supply your heart
  • You may have CPVT, which is a condition called catecholaminergic polymorphic ventricular tachycardia, a rare heart rhythm disorder that can be triggered by physical activity or emotional stress

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

  • Percutaneous stellate ganglion block

    is a procedure where medicine is injected near a group of nerves in your neck called the stellate ganglion. This treatment aims to help control abnormal heart rhythms by blocking certain nerve signals that can trigger dangerous irregular heartbeats.

  • Amiodarone

    is a medicine used to treat serious irregular heart rhythms. It works by affecting the electrical signals in your heart to help it beat in a regular pattern. In this study, it is being used as the standard treatment to compare against the nerve block procedure.

What is already known about the treatment

  • Percutaneous Stellate Ganglion Block

    This is a medical procedure, not a traditional medication, where a doctor injects an anesthetic agent near a cluster of nerves in the neck called the stellate ganglion to temporarily block their activity. It is being studied as a potential first-line treatment for electrical storm, a life-threatening condition where the heart experiences repeated dangerous rhythm disturbances. The procedure works by interrupting the nerve signals from the sympathetic nervous system that can trigger abnormal heart rhythms, helping to calm the heart's electrical activity. This intervention is classified as a nerve block procedure and is being compared to standard drug therapy to see if it can more effectively stop recurring dangerous heart rhythms in the critical first hours of treatment.

  • Amiodarone

    This is a medication given either through an injection into a vein or taken as a tablet by mouth, and it is currently considered the standard treatment for controlling serious abnormal heart rhythms. It is widely used in emergency medicine and cardiology to treat life-threatening rhythm problems of the heart, including electrical storm where the heart repeatedly beats dangerously fast or irregularly. The drug works by affecting multiple electrical pathways in the heart muscle cells, slowing down electrical signals and helping to restore a normal, steady heartbeat. Amiodarone belongs to a class of medications called antiarrhythmic agents, specifically Class III antiarrhythmics, which primarily work by prolonging the time it takes for heart cells to reset between beats.

Investigated diseases

Electrical Storm – Electrical storm is a serious heart rhythm disorder characterized by multiple episodes of ventricular arrhythmias occurring within a short period of time. The condition involves three or more separate episodes of rapid, abnormal heartbeats originating from the lower chambers of the heart within 24 hours. These irregular rhythms cause the heart to beat too quickly to pump blood effectively to the body. The episodes may occur spontaneously and repeatedly, creating a pattern of recurring cardiac events. Patients with electrical storm typically have underlying heart disease or previous heart damage. The condition requires immediate medical attention as the repeated abnormal rhythms place significant stress on the heart.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520387-34-00Protocol codeSTAR 2Estimated enrolment180 patientsSponsorFondazione IRCCS Policlinico San Matteo

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