Testing 5 mL of against a placebo for autonomic dysfunction
Official title: Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition
A Randomized Controlled Trial for Cervicothoracic Sympathetic Chain Block Against Sham Injection Evaluation for Post COVID Condition: the CeASE RCT
- Phase 4
- 2 groups
- 3 sites in Toronto
- Recruiting
Interventions
- Medication
5 mL of 0.25% bupivacaine with epinephrine (1:200,000)
The active group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 mL of 0.25% bupivacaine with epinephrine (1:200,000). After the injection, all patients will be monitored for a minimum of 30 minutes to check for expected effects of the block and to watch for any side effects or complications.
- Other intervention
Sham Group
The sham group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 ml of normal saline (0.9% NaCl). After the injection, all patients will be monitored for a minimum of 30 minutes to check for expected effects of the block and to watch for any side effects or complications.
Canadian Sites (3)
2 of 3 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario
- Recruiting
Toronto Western Hospital/UHN
Toronto, Ontario
- Not yet recruiting
Women's College Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value)
- +Allergy to local anesthetic; Inability to extend the neck for any reason (e.g. severe arthritis)
- +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 autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor.
- +Patients should be stable on any PCC-related medications for at least four weeks.
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +History of co-existing conditions that are a contraindication for SGBCSBCSB:
- +Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree
- +Infection or mass at injection siteTrial siteA hospital or clinic where a study is actually run.Read more →, 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)
- +History of prior stellate ganglion block
- +Recent history of major surgery or cerebrovascular events within the last three months
Exclusion
- −Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value)
- −Allergy to local anesthetic; Inability to extend the neck for any reason (e.g. severe arthritis)
- −History of co-existing conditions that are a contraindication for SGBCSBCSB:
- −Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree
- −Infection or mass at injection siteTrial siteA hospital or clinic where a study is actually run.Read more →, 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)
- −History of prior stellate ganglion block
- −Recent history of major surgery or cerebrovascular events within the last three months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives 5 mL of 0.25% bupivacaine with epinephrine (1:200,000).
Registry label: A: Active group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 78 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: 4-week.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Cardiac dysautonomia-related symptoms — measured over 4-week.
Cardiac dysautonomia-related symptoms — measured over 4-Week.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07468604 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 5 mL of 0.25% bupivacaine with epinephrine (1:200,000)Drug
The active group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 mL of 0.25% bupivacaine with epinephrine (1:200,000). After the injection, all patients will be monitored for a minimum of 30 minutes to check for expected effects of the block and to watch for any side effects or complications.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Sham GroupOther
The sham group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 ml of normal saline (0.9% NaCl). After the injection, all patients will be monitored for a minimum of 30 minutes to check for expected effects of the block and to watch for any side effects or complications.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4-week.
The study as a whole is currently expected to finish around 2027-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 78 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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. A key mechanism underlying many treatment-resistant PCC symptoms appears to be dysautonomia abnormal autonomic nervous system function driven by immune-mediated sympathetic overactivity. Persistent inflammation (cytokine storms, T/B-cell dysfunction, microclots) sustains sympathetic hyperactivity, which in turn perpetuates systemic inflammation and "sickness behaviors" resembling PCC symptoms. Current treatments including beta blockers, ivabradine, fludrocortisone, and rehabilitation are limited by variable responses, side effects, and the complication of post-exertional symptom exacerbation. Emerging therapies (SSRIs, low-dose naltrexone, antihistamines, HBOT) show promise but lack robust trial evidence. Cervicothoracic sympathetic chain block (CSB) a local anesthetic block of the cervical and upper thoracic sympathetic ganglia is a promising intervention that reduces sympathetic outflow, improves cerebral blood supply, and lowers pro-inflammatory cytokines. Small observational studies (16 studies, 224 patients) show benefit for PCC symptoms, but all lack placebo controls and have significant methodological heterogeneity. The proposed study aims to fill this gap with a double-blind, placebo-controlled RCT to rigorously evaluate CSB's efficacy, magnitude of benefit, and durability in PCC patients.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.