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

NCT ID: NCT06055270

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2026-05-15

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 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.

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.

Conditions

Parosmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Stellate Ganglion Block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

Other Intervention Names

SGB; sympathetic block; 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Leigh Sowerby

MD, MHM, FRCSC Associate Professor, Rhinology and Anterior Skull Base Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Hospital London

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Lanette Friesen-Waldner, Ph.D

Role: CONTACT

lanette.friesen-waldner@sjhc.london.on.ca

5196466100 ext. 61125

Cristian Dihel, MD

Role: CONTACT

cristian.dihel@sjhc.london.on.ca

Facility Contacts

Michal Kahanovitch, MsC

Role: primary

michal.kahanovitch@sjhc.london.on.ca

5196466100 ext. 61125

Leigh sowerby, MD, MHM, FRCSC

Role: backup

References

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Reference Type: BACKGROUND

PMID: 35320821 (View on PubMed)

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Reference Type: BACKGROUND

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Other Identifiers

ReDA 13983

Identifier Type: -

Identifier Source: org_study_id