Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction
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ClinicalTrials.gov Identifier: NCT05445921 |
Recruitment Status :
Completed
First Posted : July 6, 2022
Results First Posted : November 7, 2023
Last Update Posted : November 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Anosmia Hyposmia Parosmia Olfactory Disorder | Drug: Stellate Ganglion Block | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stellate Ganglion Block for the Treatment of COVID-19-Induced Olfactory Dysfunction: A Prospective Pilot Study |
Actual Study Start Date : | September 1, 2022 |
Actual Primary Completion Date : | December 12, 2022 |
Actual Study Completion Date : | December 12, 2022 |
Arm | Intervention/treatment |
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Experimental: Stellate Ganglion Block
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
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Drug: Stellate Ganglion Block
The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
Other Name: mepivacaine |
- Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: 5-10 days post SGB #1 and 1 month ]Participants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.
- University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: baseline, 5-10 days, and 1 month ]
Participants will complete the 40-item scratch and sniff UPSIT and mean change will be assessed.
The UPSIT has a minimum score of 0 and maximum score of 40 with lower scores indicating a greater degree of impairment. An UPSIT score of >33 for men and >34 for women is considered normosmic, and the minimal clinically important difference is a change of 4 points.
- Olfactory Dysfunction Outcomes Rating (ODOR) [ Time Frame: baseline, 5-10 days post SGB #1, and 1 month ]
Participants will be asked to complete the ODOR, which is a patient-reported outcome measure assessing physical problems, functional limitations, and emotional consequences of olfactory dysfunction.
The ODOR has a minimum score of 0 and a maximum score of 112 with higher scores indicating a greater degree of impairment and limitation. The minimal clinically important difference is a change of 15 points.
- Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: baseline, 5-10 days, and 1 month ]Participants will be asked about the severity of their olfactory dysfunction (and gustatory dysfunction) on a 5-point Likert scale from no smell loss to severe smell loss.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults age 18 to 70
- Diagnosis of COVID at least 12 months prior to study enrollment with self-reported olfactory dysfunction
- Objective olfactory dysfunction due to COVID-19 that has persisted despite viral recovery, as defined by the UPSIT (≤ 34 in women, ≤ 33 in men)
- Ability to read, write, and understand English
Exclusion Criteria:
- History of smell loss prior to COVID-19 infection
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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
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History of coexisting conditions that make SGB contraindicated:
- Unilateral vocal cord paralysis
- Severe COPD (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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05445921
United States, Missouri | |
Washington University School of Medicine/Barnes Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 |
Documents provided by Nyssa Farrell, Washington University School of Medicine:
Publications:
Responsible Party: | Nyssa Farrell, Nyssa Farrell, MD, Assistant Professor, Department of Otolaryngology - Head and Neck Surgery, Division of Rhinology and Anterior Skull Base Surgery, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT05445921 |
Other Study ID Numbers: |
1 |
First Posted: | July 6, 2022 Key Record Dates |
Results First Posted: | November 7, 2023 |
Last Update Posted: | November 7, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
COVID-19 |
COVID-19 Anosmia Olfaction Disorders Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Mepivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |