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NOT YET RECRUITING
NCT07468604
PHASE4

Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Controlled Trial for Cervicothoracic Sympathetic Chain Block Against Sham Injection Evaluation for Post COVID Condition: the CeASE RCT

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-04-01

Completion Date

2027-09-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

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

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.