Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the Unites States affected. Olfactory dysfunction impacts one's quality of life significantly by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory dysfunction is also an independent predictor of anxiety, depression, and even mortality. While the pandemic has increased the interest by the scientific community in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Furthermore, patients impacted by "long COVID," or chronic symptoms after an acute COVID-19 infection, experience impairments other than olfactory and gustatory dysfunction, such as chronic dyspnea, impaired memory and concentration, and severe fatigue. These symptoms have been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia. 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 prior to 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. Therefore, we propose a single cohort prospective study to generate pilot data on the efficacy and safety of sequential stellate ganglion blocks for the treatment of COVID-19-induced olfactory dysfunction and other long COVID symptoms.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Mepivacaine

Criteria

Inclusion Criteria:

1. Adults age 18 to 70

2. Diagnosis of COVID at least 12 months prior to study enrollment with self-reported olfactory dysfunction

3. Objective olfactory dysfunction due to COVID-19 that has persisted despite viral recovery, as defined by the UPSIT (≤ 34 in women, ≤ 33 in men)

4. Ability to read, write, and understand English

Exclusion Criteria:

1. History of smell loss 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 COPD (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)