Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

NCT06953661 | Not Yet Recruiting

• 1 other identifier: 80519
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postural Tachycardia Syndrome

Keywords

stellate ganglion block; regional anesthesia; nerve block

Outcome Measures

Primary Outcomes (1)

• COMPASS 31 total score

  The change in Composite Autonomic Symptom Score 31 (COMPASS-31) from baseline to first follow-up visit. The COMPASS-31 scale measures autonomic dysfunctions through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction.

  Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

Secondary Outcomes (19)

• Magnitude of postural tachycardia

  Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

• Heart rate variability (HRV)

  Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

• Plasma catecholamine levels

  Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

• Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)

  Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention

• VOSS score

  Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

Study Arms (2)

Intervention Group (stellate ganglion block)

EXPERIMENTAL

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

Procedure: Stellate ganglion block; Drug: Ropivacaine

Control Group (sham injection with saline)

SHAM COMPARATOR

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.

Procedure: Sham injection of saline; Drug: Normal saline

Interventions

Stellate ganglion block PROCEDURE

Patients will receive a SGB

Intervention Group (stellate ganglion block)

Sham injection of saline PROCEDURE

Patients will receive a subcutaneous sham injection of saline

Control Group (sham injection with saline)

Ropivacaine DRUG

The SGB group will receive ropivacaine 0.5% 10ml

Intervention Group (stellate ganglion block)

Normal saline DRUG

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

Control Group (sham injection with saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94304, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (6)

• Vernino S, Bourne KM, Stiles LE, Grubb BP, Fedorowski A, Stewart JM, Arnold AC, Pace LA, Axelsson J, Boris JR, Moak JP, Goodman BP, Chemali KR, Chung TH, Goldstein DS, Diedrich A, Miglis MG, Cortez MM, Miller AJ, Freeman R, Biaggioni I, Rowe PC, Sheldon RS, Shibao CA, Systrom DM, Cook GA, Doherty TA, Abdallah HI, Darbari A, Raj SR. Postural orthostatic tachycardia syndrome (POTS): State of the science and clinical care from a 2019 National Institutes of Health Expert Consensus Meeting - Part 1. Auton Neurosci. 2021 Nov;235:102828. doi: 10.1016/j.autneu.2021.102828. Epub 2021 Jun 5.

  PMID: 34144933 BACKGROUND

• Doherty TA, White AA. Postural orthostatic tachycardia syndrome and the potential role of mast cell activation. Auton Neurosci. 2018 Dec;215:83-88. doi: 10.1016/j.autneu.2018.05.001. Epub 2018 May 4.

  PMID: 30033040 BACKGROUND

• Duricka D, Liu L. Reduction of long COVID symptoms after stellate ganglion block: A retrospective chart review study. Auton Neurosci. 2024 Aug;254:103195. doi: 10.1016/j.autneu.2024.103195. Epub 2024 Jun 13.

  PMID: 38901177 BACKGROUND

• Pearson L, Maina A, Compratt T, Harden S, Aaroe A, Copas W, Thompson L. Stellate Ganglion Block Relieves Long COVID-19 Symptoms in 86% of Patients: A Retrospective Cohort Study. Cureus. 2023 Sep 13;15(9):e45161. doi: 10.7759/cureus.45161. eCollection 2023 Sep.

  PMID: 37711269 BACKGROUND

• Cha YM, Li X, Yang M, Han J, Wu G, Kapa SC, McLeod CJ, Noseworthy PA, Mulpuru SK, Asirvatham SJ, Brady PA, Rho RH, Friedman PA, Lee HC, Tian Y, Zhou S, Munger TM, Ackerman MJ, Shen WK. Stellate ganglion block and cardiac sympathetic denervation in patients with inappropriate sinus tachycardia. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2920-2928. doi: 10.1111/jce.14233. Epub 2019 Nov 6.

  PMID: 31625219 BACKGROUND

• Larsen NW, Stiles LE, Miglis MG. Preparing for the long-haul: Autonomic complications of COVID-19. Auton Neurosci. 2021 Nov;235:102841. doi: 10.1016/j.autneu.2021.102841. Epub 2021 Jul 3.

  PMID: 34265539 BACKGROUND

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Anna Maria Bombardieri, MD, PhD

CONTACT

3143269107; abomba@stanford.edu

Ksenia Kasimova, MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

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

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 1, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)