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Efficacy of bupivacaine hydrochloride and lidocaine hydrochloride compared with amiodarone hydrochloride as first‑line treatment for electrical storm in patients

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

Electrical storm is a condition in which the heart experiences many rapid, abnormal beats in a short time, putting a person at high risk for serious complications. The study compares a procedure called percutaneous stellate ganglion block, which involves injecting medication near a nerve cluster in the neck, with the usual medication given through a vein, amiodarone. The block uses local anesthetic medicines, either lidocaine or bupivacaine, to try to calm the heart’s rhythm.

The purpose of the study is to determine whether the nerve‑block procedure can stop the dangerous heart rhythms more effectively than the standard drug treatment during the first three hours after it is given.

Participants who are experiencing an electrical storm are randomly assigned to receive either the nerve block or the intravenous medication. After the treatment, they are monitored for at least three hours to see if the abnormal beats are fully suppressed, and further observation continues for a short period to assess safety and any additional effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After you join the study, you are randomly assigned to one of two treatment groups. the assignment is done by the study system and you do not choose the group.

  2. Step 2

    Receive assigned treatment

    If you are assigned to the test group, you receive a percutaneous stellate ganglion block. the block is performed by injecting a mixture of lidocaine (600 mg) and bupivacaine (150 mg) near the stellate ganglion using a paravertebral approach. the injection is given as a single dose at the time of the procedure.

    If you are assigned to the comparator group, you receive an intravenous injection of amiodarone (1200 mg). the injection is given as a single dose through a vein.

  3. Step 3

    Monitoring period

    After the treatment, you are monitored continuously for at least three hours. medical staff watch for any recurrence of ventricular arrhythmias, which are abnormal heart rhythms that can cause an electrical storm.

    If a ventricular arrhythmia occurs, the staff may use antitachycardia pacing (atp), an internal dc shock, or an external dc shock to try to stop it.

  4. Step 4

    Assessment of treatment effect

    At the end of the three‑hour monitoring period, doctors evaluate whether the ventricular arrhythmias have been completely suppressed. this assessment determines if the treatment was successful during the observation window.

  5. Step 5

    Post‑assessment care

    Based on the assessment result, you continue to receive standard medical care as directed by your physician. the study does not specify additional procedures beyond the three‑hour observation.

Who can join the trial?

7 criteria

  • Must be at least 18 years old.
  • Must have had more than three episodes of a fast heart rhythm called ventricular tachycardia (VT) or ventricular fibrillation (VF) that required a shock from an internal or external defibrillator (a device that delivers an electric shock) in the 12 hours before being considered for the study, and at least one episode in the three hours before.
  • Must currently have a fast VT or VF that needs treatment with a defibrillator.
  • Must have any type of structural heart disease (meaning the heart’s shape or muscle is abnormal).
  • Must have acute (recent) or chronic (long‑standing) coronary disease (problems with the blood vessels that supply the heart).
  • Must have CPVT, which stands for catecholaminergic polymorphic ventricular tachycardia, a genetic condition that causes fast heart rhythms during stress or exercise.
  • Both men and women are eligible to take part.

Who cannot join the trial?

17 criteria

  • You cannot join if you have Brugada syndrome (a rare heart rhythm disorder) or early repolarization syndrome (a pattern on heart tests that can cause irregular beats).
  • You cannot join if you are allergic or unusually sensitive to any of the study medicines such as amiodarone, lidocaine, bupivacaine, or any of their inactive ingredients.
  • You cannot join if you have conditions that make the study drugs unsafe, including:
    • QT interval prolongation or Long‑QT syndrome (a heart rhythm problem that can cause dangerous fast beats),
    • Sick sinus syndrome (the heart’s natural pacemaker does not work well) without having a pacemaker implanted,
    • second‑ or third‑degree AV block (the signal from the upper to the lower heart chambers is blocked) without a pacemaker,
    • active hyperthyroidism (overactive thyroid gland),
    • severe low blood pressure (hypotension),
    • Porphyria (a disorder affecting the blood’s ability to carry oxygen),
    • untreated pheochromocytoma (a tumor that can raise blood pressure).
    • You cannot join if doctors decide that your neck anatomy makes the procedure impossible.
    • You cannot join if you have had a previous heart transplant.
    • You cannot join if you have previously had surgical removal of part of the nervous system that controls heart rhythm (surgical sympathetic denervation).
    • You cannot join if you have previously had an ablation (a procedure that destroys tissue) of the stellate ganglion block (a nerve area near the neck).
    • You cannot join if you are currently receiving intravenous anti‑arrhythmic drugs (medicines given through a vein to control heart rhythm), unless special circumstances allow it.
    • You cannot join if you have experienced a refractory cardiac arrest (a heart stop that does not respond to standard treatments).
    • You cannot join if you have taken any investigational drug in a clinical trial within the past 30 days, or within five times the time it takes for the study drug to leave your body (whichever is longer).
    • You cannot join if you are pregnant or breastfeeding.
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Investigated drugs

  • Amiodarone

    is a medication that doctors often give to patients who have dangerous heart rhythm problems. In this study it is used as the standard treatment to compare against the new approach. It is given through an IV line and works by helping the heart beat in a more normal rhythm.

  • Lidocaine

    is a local anesthetic that can also help control abnormal heart rhythms. In the trial it is injected near the spine (paravertebral use) as part of the test treatment. It works by temporarily blocking the electrical signals that cause the heart to beat irregularly.

  • Bupivacaine

    is another local anesthetic that is stronger and lasts longer than lidocaine. It is also injected near the spine in the study’s test group. Its purpose is to numb the area and help stop the faulty heart signals that lead to an electrical storm.

  • Percutaneous Stellate Ganglion Block

    is a minimally invasive procedure where a doctor inserts a thin needle through the skin to reach a small group of nerves in the neck called the stellate ganglion. By delivering medication (such as lidocaine or bupivacaine) to this spot, the block aims to calm the nervous system’s influence on the heart, reducing the number of dangerous heart rhythm episodes during an electrical storm.

What is already known about the treatment

  • Amiodarone

    This drug is given by slow intravenous injection as a clear solution. It is an established, approved medication widely used in hospitals for heart rhythm problems and is well described in medical literature. It is mainly used to stop dangerous ventricular arrhythmias such as electrical storm. It works by blocking potassium channels and also affecting sodium, calcium and beta‑receptor activity, which lengthens the heart’s electrical recovery time; it belongs to the class III anti‑arrhythmic drugs.

  • Lidocaine

    The medication is injected near the spine (paravertebral use) as a sterile solution for regional anesthesia. It is an approved local anesthetic and also listed in guidelines for emergency heart rhythm control, with extensive clinical data available. It is used to numb tissue for procedures and can help control ventricular arrhythmias. It blocks sodium channels in nerves, stopping the flow of electrical signals that cause pain or abnormal heart beats; it is classified as an amide‑type local anesthetic and a class Ib anti‑arrhythmic.

  • Bupivacaine

    This drug is also administered by paravertebral injection as a sterile solution for long‑lasting nerve block. It is a widely accepted, approved long‑acting local anesthetic with a solid record in medical publications. It is used to provide extended regional anesthesia for surgeries and pain control. It works by blocking sodium channels more strongly and for a longer time than shorter‑acting agents, preventing nerve signals; it is classified as an amide‑type, long‑acting local anesthetic.

Investigated diseases

Electrical storm - A rapid succession of three or more episodes of ventricular tachycardia or ventricular fibrillation occurring within a 24‑hour period. Each episode can start and stop on its own, but the overall pattern shows increasing frequency. The condition often begins with isolated abnormal heartbeats that become more frequent and sustained over time. As the episodes accumulate, the heart’s rhythm becomes increasingly unstable, leading to repeated urgent interventions to restore normal beating.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520387-34-01Protocol codeSTAR 2Estimated enrolment180 patientsSponsorFondazione IRCCS Policlinico San Matteo

sourced from the EU Clinical Trials Register and site verification

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