Health TrialsbyHealthPanel

Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

ConditionPostural Tachycardia Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Stellate ganglion block

    Procedure/Surgery

    Patients will receive a SGB

  • Sham injection of saline

    Procedure/Surgery

    Patients will receive a subcutaneous sham injection of saline

  • Ropivacaine

    Drug

    The SGB group will receive ropivacaine 0.5% 10ml

  • Normal saline

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Intervention Group (stellate ganglion block)Experimental treatment 2 interventions
Group B: Control Group (sham injection with saline)Sham comparator 2 interventions

Trial outcomes

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.

Time frame
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

1

Magnitude of postural tachycardia

Change in magnitude of postural tachycardia (a heart rate increase within the first 10 minutes of standing) from baseline to first and second follow up visit.

Time frame
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)
2

Heart rate variability (HRV)

Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit

Time frame
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)
3

Plasma catecholamine levels

Measure the change in plasma catecholamine levels from baseline to first and second follow up visits

Time frame
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)
4

Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)

SPOTS evaluates the frequency and severity of common POTS symptoms, The higher the score, the greater the symptom burden. A reduction in SPOTS score suggests clinical improvement. SPOTS scores at 1st and 2nd FU are compared to baseline SPOTS scores.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: