Actively Recruiting
A Randomized Controlled Trial for Cervicothoracic Sympathetic Chain Block Against Sham Injection Evaluation for Post COVID Condition: the CeASE RCT
Led by University Health Network, Toronto · Updated on 2026-06-08
78
Participants Needed
3
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of cervicothoracic sympathetic chain block (CSB) on Post-COVID Condition (PCC), a condition affecting about 2.1 million Canadians with symptoms like fatigue, brain fog, palpitations, and orthostatic intolerance. PCC involves abnormal autonomic nervous system function driven by immune-mediated sympathetic overactivity and persistent inflammation, which contributes to ongoing symptoms. Current treatments have limited success, and this study aims to rigorously evaluate CSB's efficacy in reducing these symptoms in a controlled trial setting. The study compares two groups: one receiving CSB on both sides using up to 5 mL of 0.25% bupivacaine with epinephrine, and a sham group receiving injections of normal saline. Both groups will be monitored for at least 30 minutes after injections to observe effects and side effects. This double-blind, randomized, placebo-controlled trial will assess the benefits and duration of symptom relief from CSB in PCC patients. Participants will undergo assessments including symptom questionnaires focusing on cardiac dysautonomia-related symptoms over four weeks. The study will monitor participants for safety and effectiveness throughout the trial. Researchers will measure changes in autonomic symptoms to determine the impact of CSB treatment. The study involves adults 18 years and older with PCC symptoms lasting at least three months and requires stable medication use and understanding of English. Total participation duration and follow-up details are based on the study schedule to evaluate symptom changes.
CONDITIONS
Brief Title
Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Post-COVID Condition following COVID-19 infection with symptoms lasting at least three months
- Ability to read, write, and understand English
- Autonomic symptoms reported on the Composite Autonomic Symptom Score (COMPASS-31) with a score greater than 0
- Stable on any Post-COVID Condition-related medications for at least four weeks
You will not qualify if you...
- Unilateral vocal cord paralysis
- Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted)
- Recent myocardial infarction within the last year
- Cardiac conduction block of any degree
- Glaucoma
- Infection or mass at injection site
- Bleeding disorders
- Active autoimmune disorders
- Pre-existing autonomic dysfunction prior to COVID-19 (e.g., POTS, IST, CRPS)
- Untreated psychiatric conditions requiring medication adjustments during the study
- Major surgery or cerebrovascular events within the last three months
- Allergy to local anesthetic
- Inability to extend the neck for any reason
- History of prior stellate ganglion block
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit with at least 30 minutes monitoring
Participants receive cervical sympathetic block injections on both the left and right sides with either active medication or a sham saline injection, followed by monitoring for side effects.
1 treatment and monitoring visit (in-person)
Duration - 4 weeks
Participants are monitored for cardiac dysautonomia-related symptoms for up to 4 weeks after treatment.
Follow-up visits to assess symptoms (visit schedule not specified)
Trial Site Locations
Total: 3 locations
1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B3
Not Yet Recruiting
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
3
Toronto Western Hospital/UHN
Toronto, Ontario, Canada
Actively Recruiting
Research Team
E
Emad Al Azazi, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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