Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

Stanford University

Status: Not yet enrolling

Conditions: Postural Tachycardia Syndrome

Treatments: Drug: Ropivacaine; Procedure: Sham injection of saline; Drug: Normal saline; Procedure: Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT06953661

80519

Details and patient eligibility

About

This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.

Full description

Postural Tachycardia Syndrome (POTS) is a heterogeneous condition affecting approximately 0.2% of the global population, predominantly young women of childbearing age. It is characterized by significant functional impairment and a constellation of symptoms, including lightheadedness, cognitive dysfunction, blurred vision, irritability, palpitations, and chest discomfort, which occur upon standing and improve when lying down. Although current pharmacological and non-pharmacological treatments alleviate symptoms for some patients, many remain significantly disabled. These challenges highlight the urgent need for novel treatment strategies, particularly non-pharmacological approaches.

This study is a randomized controlled trial with a control group. The study team will enroll 20 patients with POTS, assigning 10 to the intervention group and 10 to the control group.

The goal of the study is to evaluate the effectiveness of SGB in improving heart rate, markers of sympathetic hyperactivity, and POTS symptoms comparing to a sham saline injection.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years of age) diagnosed with POTS
• Ability to provide informed consent
• Ability to comply with 3 follow up visits
• English speaking and capable of signing informed consent and complying with protocol requirements

Exclusion criteria

• Allergy to local anesthetics
• Severe coagulopathy
• History of or currently being treated for clinically significant ongoing cardiac arrhythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS
• Inability to maintain a stable medication regiment for the duration of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Intervention Group (stellate ganglion block)

Experimental group

Description:

Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine.

Treatment:

Procedure: Stellate ganglion block

Drug: Ropivacaine

Control Group (sham injection with saline)

Sham Comparator group

Description:

Patients will receive a subcutaneous sham injection with saline. Ultrasound imaging will be used to simulate the guidance process as in the active procedure, maintaining consistency in the procedural experience.

Treatment:

Drug: Normal saline

Procedure: Sham injection of saline