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

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ClinicalTrials.gov Identifier: NCT06055270
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Parosmia Procedure: Stellate Ganglion Block Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blinded, Placebo-Controlled Randomized Clinical Trial
Masking: Double (Participant, Investigator)
Masking Description: Study statistician
Primary Purpose: Treatment
Official Title: Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia: Double-Blinded, Placebo-Controlled Randomized Clinical Trial
Actual Study Start Date : February 15, 2024
Estimated Primary Completion Date : December 24, 2025
Estimated Study Completion Date : May 15, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arm Intervention/treatment
Placebo Comparator: 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.
Other: 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
Other Name: Placebo sham injection

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.
Procedure: 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.
Other Names:
  • SGB
  • sympathetic block




Primary Outcome Measures :
  1. Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR) [ Time Frame: Baseline, 1, 3, and 12 months after SGB ]
    The DisODOR is a disease-specific questionnaire that assesses for physical problems, functional limitations, and emotional consequences of parosmia secondary to any etiology. The instrument contains 29 total items with each scored on a 5-point Likert scale from 0 to 4. The minimal clinically important difference (MCID) for the instrument is 15.


Secondary Outcome Measures :
  1. Clinical Global Impression - Severity Scale (CGI-S) [ Time Frame: Baseline ]
    The baseline severity of parosmia will be measured with the CGI-S scale. The CGI-S scale measures disease severity in clinical condition based on a 5-point Likert scale.

  2. Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: 1, 3, and 12 months after SGB ]
    The overall response to treatment will be measured with the CGI-I scale. The CGI-I Scale measures response to treatment for a number of disorders and has good internal consistency and validity.32 The CGI-I scale measures change in clinical condition based on a 7-point Likert scale. The CGI-I for parosmia asks, "Compared to before your stellate ganglion block, how would you describe your parosmia (things do not smell the same as you remember)?" Response options for each are: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Responders are defined as those who report "slightly better now than before" or greater.

  3. University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey). [ Time Frame: Baseline ]
    The UPSIT is a test of olfactory identification and consists of four 10-page booklets, with a total of 40 items. On each page, there is a different "scratch and sniff" strip and four choice options. Subjects are asked to scratch each strip with a pencil to release the scents, detect the smell, and identify the smell from the four choice options. The UPSIT comes from a scoring rubric that identifies the normalcy benchmark based on age and gender, which is >34 in women and >33 in men.33,34 The UPSIT is commercially available, takes 10-15 minutes to complete, and is the gold standard test to assess smell identification. The minimal clinically important difference of the UPSIT is 4.

  4. Long-COVID Questionnaire (LCQ) [ Time Frame: Baseline, 1, 3, and 12 months after SGB ]
    Symptoms assessed via the LCQ are derived from the Symptom Burden Questionnaire for Long Covid35, which included tiredness/fatigue, shortness of breath, brain fogginess, headache, cough, depression, low-grade fevers, palpitations, dizziness, muscle pain, and joint pains. At baseline, participants are asked to rank the current severity of each problem on a 5-point Likert scale. At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.

  5. Olfaction Catastrophizing Scale (OCS) [ Time Frame: Baseline, 1, 3, and 12 months after SGB ]
    The pain catastrophizing scale (PCS) was developed to measure the negative mental response to actual or anticipated pain. The OCS was derived from the validated PCS to similarly measure the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. At each visit, subjects will be asked to complete the OCS.

  6. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 1, 3, and 12 months after SGB ]
    The HADS was developed for screen for anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression. Subjects will be screened for anxiety and depression on their initial visit.

  7. Pre-Intervention Expectations [ Time Frame: Baseline ]
    A significant number of social media and news stories have discussed anecdotal success of stellate ganglion blocks for COVID-19-induced olfactory dysfunction. As a result, we propose that participants may have a distorted pre-operative expectation that may affect their subjective rating of improvement in olfaction. Therefore, participants will be asked at baseline, "How confident are you that the stellate ganglion block will improve your smell loss or smell distortion?" Possible answer choices: Not at all, Slightly confident, Somewhat confident, Very confident, Extremely confident.

  8. Patient Satisfaction with Treatment [ Time Frame: 1, 3, and 12 months after SGB ]
    Participants will be asked at the 1-month virtual visit, "Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?" Possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied. Patients will also be asked at the final visit, "Would you recommend this treatment to a family member or close friend who also suffers from chronic smell loss due to COVID-19?" Possible answer choices: 1) Yes, 2) No.

  9. Assessment of the Blind [ Time Frame: 1 Month after SGB ]
    Immediately after the initial injection, participants will be asked, "Which intervention do you think you received?" Answer choices: 1)Lidocaine (active medication) 2) Saline (placebo).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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): NCT06055270


Contacts
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Contact: Taciano Rocha, Ph.D 5196466100 ext 61125 taciano.rocha@sjhc.london.on.ca
Contact: Michal Kahanovitch, MSc michal.kahanovitch@sjhc.london.on.ca

Locations
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Canada, Ontario
St. Joseph's Hospital London Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Michal Kahanovitch, MsC    5196466100 ext 61125    michal.kahanovitch@sjhc.london.on.ca   
Principal Investigator: Leigh sowerby, MD, MHM, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Publications of Results:

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Responsible Party: Leigh Sowerby, MD, MHM, FRCSC Associate Professor, Rhinology and Anterior Skull Base Surgery, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT06055270    
Other Study ID Numbers: ReDA 13983
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leigh Sowerby, Lawson Health Research Institute:
Long-COVID
Olfactory disfunction
smell
olfaction
anosmia
bad smell
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases