Clinical Research Directory
Browse clinical research sites, groups, and studies.
Stellate Ganglion Neuromodulation for the Treatment of Electrical Storm
Sponsor: Population Health Research Institute
Summary
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.
Official title: STellate gangliOn neuRoModulatiOn For the Treatment oF Electrical Storm: a Randomized Sham-controlled Trial (STORM-OFF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2027-01
Completion Date
2031-07
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Stellate Ganglion Block Injection with Bupivicaine
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.
Sham procedure control
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.
Locations (1)
Population Health Research Institute
Hamilton, Ontario, Canada