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New treatment option for Autonomic Dysfunction
Official title Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition
ClinicalTrials.gov ID: NCT07468604
What this study is testing
What is 5 mL of 0.25% bupivacaine with epinephrine (1:200,000)?
5 mL of 0.25% bupivacaine with epinephrine (1:200,000) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for autonomic dysfunction.
Also referred to as Active group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Post-COVID Condition (PCC) affects roughly 2.1 million Canadians, carrying an annual economic burden of CAD $7.8-50.6 billion. It presents across multiple organ systems with symptoms including fatigue, brain fog, palpitations, and orthostatic intolerance, at an annual cost of CAD $1,675-$7,340 per case.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- PCC following COVID-19 infection with symptoms lasting for at least three months
- Ability to read, write, and understand English
- Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31)...
- Patients should be stable on any PCC-related medications for at least four weeks.
You likely can't join if
- History of co-existing conditions that are a contraindication for SGBCSBCSB:
- Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value)
- Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree
- Glaucoma
- Infection or mass at injection site, bleeding disorders
- Comorbid conditions that could confound study results, such as:
See the full eligibility criteria
- Age 18 years or older
- PCC following COVID-19 infection with symptoms lasting for at least three months
- Ability to read, write, and understand English
- Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31), i.e. a COMPASS-31 score greater than 0. COMPASS-31 assesses 6 domains of...
- Patients should be stable on any PCC-related medications for at least four weeks.
- History of co-existing conditions that are a contraindication for SGBCSBCSB:
- Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value)
- Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree
- Glaucoma
- Infection or mass at injection site, bleeding disorders
- Comorbid conditions that could confound study results, such as:
- Active autoimmune disorders
- Pre-existing autonomic dysfunction (e.g. POTS, IST, and CRPS) prior to COVID-19
- Untreated psychiatric conditions (e.g. severe anxiety or PTSD requiring medication adjustments during the study period)
- Recent history of major surgery or cerebrovascular events within the last three months
- Allergy to local anesthetic; Inability to extend the neck for any reason (e.g. severe arthritis)
- History of prior stellate ganglion block
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.