Evaluating the Effectiveness of Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Post-Acute Sequelae of SARS-CoV-2 (PASC)

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing

• Persistent symptoms that continue four or more weeks after the start of a COVID-19 infection

• Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31). The COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor.

• Quantified pain symptoms of pain interference or pain intensity as reported by the patient on the screener Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Locations
United States
New York
Hudson Medical
New York
Time Frame
Start Date: 2023-01-03
Completion Date: 2023-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Active
This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).
Sponsors
Leads: Jonathann Kuo, MD

This content was sourced from clinicaltrials.gov