Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 5 mL of 0.25% bupivacaine with epinephrine (1:200,000)
  • Sham Group

Treatment groups

78 Participants
are divided into 2 treatment groups