Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postural Tachycardia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Twenty patients will be enrolled, with 10 patients allocated to each study arm (treatment and control).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention Group (stellate ganglion block)

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

Group Type EXPERIMENTAL

Stellate ganglion block

Intervention Type PROCEDURE

Patients will receive a SGB

Ropivacaine

Intervention Type DRUG

The SGB group will receive ropivacaine 0.5% 10ml

Control Group (sham injection with saline)

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.

Group Type SHAM_COMPARATOR

Sham injection of saline

Intervention Type PROCEDURE

Patients will receive a subcutaneous sham injection of saline

Normal saline

Intervention Type DRUG

The control group will receive normal saline in the sham injection.

Interventions

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Stellate ganglion block

Patients will receive a SGB

Intervention Type PROCEDURE

Sham injection of saline

Patients will receive a subcutaneous sham injection of saline

Intervention Type PROCEDURE

Ropivacaine

The SGB group will receive ropivacaine 0.5% 10ml

Intervention Type DRUG

Normal saline

The control group will receive normal saline in the sham injection.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No