Official Title
Stellate Ganglion Block with Lidocaine for the Treatment of COVID-19-Induced Parosmia: Double-Blinded, Placebo-Controlled Randomized Clinical Trial
Brief Summary

Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic isa growing public health crisis, affecting up to 1.2 million people in the United States.Olfactory dysfunction significantly impacts one's quality of life by decreasing theenjoyment of foods, creating environmental safety concerns, and affecting one's abilityto perform specific jobs. Olfactory loss is also an independent predictor of anxiety,depression, and mortality.Recent research suggests that parosmia, more so than hyposmia, can increase anxiety,depression, and even suicidal ideation. While the pandemic has advanced the scientificcommunity's interest in combating the burgeoning health crisis, few effective treatmentscurrently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19infection, or "Long COVID" symptoms, have been hypothesized to result from sympatheticnervous system dysfunction. Stellate ganglion blocks have been proposed to treat thishyper-sympathetic activation by blocking the sympathetic neuronal firing and resettingthe balance of the autonomic nervous system. Studies before the COVID-19 pandemic havesupported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, andrecent news reports and a published case series have described a dramatic benefit in botholfactory function and other long COVID symptoms in patients receiving stellate ganglionblocks. A previous pilot study using stellate ganglion blocks of 20 participants withpersistent COVID-19 olfactory dysfunction resulted in modest improvements in subjectiveolfactory function, smell identification, and olfactory-specific quality of life, but itlacked a control group.Therefore, we propose a double-blinded, placebo-controlled, randomized clinical trialassessing the efficacy of a stellate ganglion block with Lidocaine versus salineinjection in up to 50 participants with persistent COVID-19-associated olfactorydysfunction.

Detailed Description

This will be a double-blinded, placebo-controlled, randomized clinical to assess the
efficacy of Stellate Ganglion Block with Lidocaine 1% (8mL). Participants with parosmia
will be randomly assigned to SGB with Lidocaine 1% (8mL) or Placebo (saline solution).
Baseline assessment will happen in person and will consist on demographic information,
Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR), Clinical Global Impression:
Severity Scale (CGI-S), University of Pennsylvania Smell Identification Test (UPSIT),
Long-COVID Questionnaire (LCQ), Olfaction Catastrophizing Scale (OCS), Hospital Anxiety
and Depression Scale (HADS), Pre-Intervention Expectations. Then, after the assigned
interventional procedures are performed three remote visits will be performed as
follow-ups (1, 3, and 12 months), in which the variables above will be reassessed.

Recruiting
Parosmia

Procedure: Stellate Ganglion Block

All SGBs will be performed by a board-certified anesthesiologist and pain management
specialist with extensive experience performing SGBs. The laterality of the SGB will be
randomized between the left and right sides of the neck. Participants will be asked to
abstain from eating and drinking for 8 hours prior to the SGB. Using ultrasound guidance,
the transverse process of the C6 vertebra is identified. Color-doppler is used to
identify blood vessels. A 27-gauge needle is used to anesthetize the superficial skin
with 1% lidocaine. Then, a 21-gauge ultrasound needle is advanced using an in-plane
technique from lateral to medial with careful avoidance of neurovascular structures.
After negative aspiration, 8 mL of 1% Lidocaine is deposited beneath the prevertebral
fascia and above the Longus coli muscle into the stellate ganglion.
Other Name: SGB,sympathetic block

Other: Placebo

The placebo sham injection will be performed in an identical fashion as the stellate
ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of
Lidocaine
Other Name: Placebo sham injection

Eligibility Criteria

Inclusion Criteria:

1. Adults age 18 to 70

2. Diagnosis of COVID-19 at least 6 months prior to study enrollment with self-reported
parosmia

3. Ability to read, write, and understand English

4. Score of at least 15 on DiSODOR

Exclusion Criteria:

1. History of smell loss or change prior to COVID-19 infection

2. History of conditions known to impact olfactory function:

1. Chronic rhinosinusitis

2. History of prior sinonasal or skull base surgery

3. Neurodegenerative disorders (Parkinson's disease, Huntington's disease,
Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)

3. Currently using concomitant therapies specifically for the treatment of olfactory
dysfunction

4. Inability to tolerate a needle injection into the neck

5. History of coexisting conditions that make SGB contraindicated:

1. Unilateral vocal cord paralysis

2. Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted)

3. Recent myocardial infarction within the last year

4. Glaucoma

5. Cardiac conduction block of any degree

6. Currently taking blood thinners or antiplatelet agents

7. Allergy to local anesthetic

8. Inability to extend the neck for any reason (e.g., severe arthritis)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
Canada
Locations

St. Joseph's Hospital London
London, Ontario, Canada

Investigator: Michal Kahanovitch, MsC
Contact: 5196466100
michal.kahanovitch@sjhc.london.on.ca

Contacts

Lanette Friesen-Waldner, Ph.D
5196466100 - 61125
lanette.friesen-waldner@sjhc.london.on.ca

Not Provided

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
NCT Number
Keywords
Long-COVID
Olfactory disfunction
smell
Olfaction
anosmia
bad smell
MeSH Terms
Olfaction Disorders