Stellate Ganglion Block for Ventricular Tachycardia
(STORM-OFF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Ventricular tachycardia (VT) is a serious heart rhythm problem in which the heart beats very fast and in an abnormal way. These abnormal heart rhythms can be life-threatening. When a person has three or more episodes of VT within a 24-hour period, it is called a "VT storm." VT storm can be difficult to treat because some patients do not respond well to standard medications. Some studies suggest that a procedure called a stellate ganglion block (SGB) may help. An SGB involves injecting a local anesthetic near a group of nerves in the neck that help control signals between the brain and the heart. The procedure can be performed at the bedside using ultrasound guidance.
The purpose of this study is to find out whether SGB can delay or prevent the return of dangerous abnormal heart rhythms in patients with VT storm who are receiving care in an intensive care unit.
If a patient joins the study, they will be randomly assigned (by chance, like flipping a coin) to one of two groups. One group will receive a real stellate ganglion block. The other group will receive a sham procedure, in which a blunt needle will touch the skin but no injection will be given. Patients in the sham group who continue to experience VT may later receive the real procedure.
Participants will be followed until they leave the hospital or for 30 days after joining the study, whichever comes first. The study will take place at five hospitals across Ontario.
Are You a Good Fit for This Trial?
This trial is for adults in the intensive care unit who are experiencing a 'VT storm,' meaning they have had three or more episodes of dangerous fast heart rhythms (ventricular tachycardia) within 24 hours and need urgent treatment.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Stellate Ganglion Block Injection with Bupivicaine
Trial Overview
The study compares two groups: one receives a stellate ganglion block (an injection of numbing medicine near nerves in the neck), while the other gets a sham procedure with no real injection. Participants are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes.
The sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Population Health Research Institute
Lead Sponsor
Hamilton Health Sciences Hospital
Collaborator
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