Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06055270

Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-10-23

44

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a 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 the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to 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 scientific community's interest in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or "Long COVID" symptoms, have been hypothesized to result from sympathetic nervous system dysfunction. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies before the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted in modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality of life, but it lacked a control group. Therefore, we propose a double-blinded, placebo-controlled, randomized clinical trial assessing the efficacy of a stellate ganglion block with Lidocaine versus saline injection in up to 50 participants with persistent COVID-19-associated olfactory dysfunction.

CONDITIONS

Official Title

Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults age 18 to 70
  • Diagnosis of COVID-19 at least 6 months prior with self-reported parosmia
  • Ability to read, write, and understand English
  • Score of at least 15 on Parosmia Olfactory Dysfunction Outcomes Rating (DiSODOR)
Not Eligible

You will not qualify if you...

  • History of smell loss or change before COVID-19 infection
  • History of chronic rhinosinusitis
  • History of prior sinonasal or skull base surgery
  • Diagnosis of neurodegenerative disorders such as Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, or frontotemporal dementia
  • Currently using treatments specifically for olfactory dysfunction
  • Unable to tolerate a needle injection into the neck
  • History of unilateral vocal cord paralysis
  • Severe chronic obstructive pulmonary disease with FEV1 between 30-50% predicted
  • Myocardial infarction within the last year
  • Glaucoma
  • Any degree of cardiac conduction block
  • Currently taking blood thinners or antiplatelet agents
  • Allergy to local anesthetic
  • Inability to extend the neck (e.g., due to severe arthritis)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Joseph's Hospital London

London, Ontario, Canada, N6A 4V2

Actively Recruiting

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Research Team

L

Lanette Friesen-Waldner, Ph.D

CONTACT

C

Cristian Dihel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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