Status:
RECRUITING
Stellate Ganglion Block with Lidocaine for the Treatment of COVID-19-Induced Parosmia
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Parosmia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 ...
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 t...
Eligibility Criteria
Inclusion
- Adults age 18 to 70
- Diagnosis of COVID-19 at least 6 months prior to study enrollment with self-reported parosmia
- Ability to read, write, and understand English
- Score of at least 15 on DiSODOR
Exclusion
- History of smell loss or change prior to COVID-19 infection
- History of conditions known to impact olfactory function:
- Chronic rhinosinusitis
- History of prior sinonasal or skull base surgery
- Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)
- Currently using concomitant therapies specifically for the treatment of olfactory dysfunction
- Inability to tolerate a needle injection into the neck
- History of coexisting conditions that make SGB contraindicated:
- Unilateral vocal cord paralysis
- Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted)
- Recent myocardial infarction within the last year
- Glaucoma
- Cardiac conduction block of any degree
- Currently taking blood thinners or antiplatelet agents
- Allergy to local anesthetic
- Inability to extend the neck for any reason (e.g., severe arthritis)
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06055270
Start Date
February 15 2024
End Date
May 15 2026
Last Update
October 23 2024
Active Locations (1)
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1
St. Joseph's Hospital London
London, Ontario, Canada, N6A 4V2