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

NCT06055270 | Recruiting Phase 3

• 1 other identifier: ReDA 13983
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Parosmia

Keywords

Long-COVID; Olfactory disfunction; smell; olfaction; anosmia; bad smell

Outcome Measures

Primary Outcomes (1)

• Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)

  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.

  Baseline, 1, 3, and 12 months after SGB

Secondary Outcomes (9)

• Clinical Global Impression - Severity Scale (CGI-S)

  Baseline

• Clinical Global Impression - Improvement Scale (CGI-I)

  1, 3, and 12 months after SGB

• University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey).

  Baseline

• Long-COVID Questionnaire (LCQ)

  Baseline, 1, 3, and 12 months after SGB

• Olfaction Catastrophizing Scale (OCS)

  Baseline, 1, 3, and 12 months after SGB

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Stellate Ganglion Block

EXPERIMENTAL

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

Interventions

Stellate Ganglion Block 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.

Also known as: SGB, sympathetic block

Stellate Ganglion Block

Placebo 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

Also known as: Placebo sham injection

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Hospital London

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (10)

• Hintschich CA, Fischer R, Hummel T, Wenzel JJ, Bohr C, Vielsmeier V. Persisting olfactory dysfunction in post-COVID-19 is associated with gustatory impairment: Results from chemosensitive testing eight months after the acute infection. PLoS One. 2022 Mar 23;17(3):e0265686. doi: 10.1371/journal.pone.0265686. eCollection 2022.

  PMID: 35320821 BACKGROUND

• Fortunato F, Martinelli D, Iannelli G, Milazzo M, Farina U, Di Matteo G, De Nittis R, Ascatigno L, Cassano M, Lopalco PL, Prato R. Self-reported olfactory and gustatory dysfunctions in COVID-19 patients: a 1-year follow-up study in Foggia district, Italy. BMC Infect Dis. 2022 Jan 22;22(1):77. doi: 10.1186/s12879-022-07052-8.

  PMID: 35065619 BACKGROUND

• Khan AM, Kallogjeri D, Piccirillo JF. Growing Public Health Concern of COVID-19 Chronic Olfactory Dysfunction. JAMA Otolaryngol Head Neck Surg. 2022 Jan 1;148(1):81-82. doi: 10.1001/jamaoto.2021.3379.

  PMID: 34792577 BACKGROUND

• Lerner DK, Garvey KL, Arrighi-Allisan AE, Filimonov A, Filip P, Shah J, Tweel B, Del Signore A, Schaberg M, Colley P, Govindaraj S, Iloreta AM. Clinical Features of Parosmia Associated With COVID-19 Infection. Laryngoscope. 2022 Mar;132(3):633-639. doi: 10.1002/lary.29982. Epub 2021 Dec 13.

  PMID: 34870334 BACKGROUND

• Schambeck SE, Crowell CS, Wagner KI, D'Ippolito E, Burrell T, Mijocevic H, Protzer U, Busch DH, Gerhard M, Poppert H, Beyer H. Phantosmia, Parosmia, and Dysgeusia Are Prolonged and Late-Onset Symptoms of COVID-19. J Clin Med. 2021 Nov 12;10(22):5266. doi: 10.3390/jcm10225266.

  PMID: 34830550 BACKGROUND

• Hopkins C, Surda P, Vaira LA, Lechien JR, Safarian M, Saussez S, Kumar N. Six month follow-up of self-reported loss of smell during the COVID-19 pandemic. Rhinology. 2021 Feb 1;59(1):26-31. doi: 10.4193/Rhin20.544.

  PMID: 33320115 BACKGROUND

• Keller A, Malaspina D. Hidden consequences of olfactory dysfunction: a patient report series. BMC Ear Nose Throat Disord. 2013 Jul 23;13(1):8. doi: 10.1186/1472-6815-13-8.

  PMID: 23875929 BACKGROUND

• Santos DV, Reiter ER, DiNardo LJ, Costanzo RM. Hazardous events associated with impaired olfactory function. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):317-9. doi: 10.1001/archotol.130.3.317.

  PMID: 15023839 BACKGROUND

• Pang NY, Song HJJMD, Tan BKJ, Tan JX, Chen ASR, See A, Xu S, Charn TC, Teo NWY. Association of Olfactory Impairment With All-Cause Mortality: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):436-445. doi: 10.1001/jamaoto.2022.0263.

  PMID: 35389456 BACKGROUND

• Addison AB, Wong B, Ahmed T, Macchi A, Konstantinidis I, Huart C, Frasnelli J, Fjaeldstad AW, Ramakrishnan VR, Rombaux P, Whitcroft KL, Holbrook EH, Poletti SC, Hsieh JW, Landis BN, Boardman J, Welge-Lussen A, Maru D, Hummel T, Philpott CM. Clinical Olfactory Working Group consensus statement on the treatment of postinfectious olfactory dysfunction. J Allergy Clin Immunol. 2021 May;147(5):1704-1719. doi: 10.1016/j.jaci.2020.12.641. Epub 2021 Jan 13.

  PMID: 33453291 BACKGROUND

MeSH Terms

Conditions

Olfaction Disorders; Post-Acute COVID-19 Syndrome; Anosmia

Interventions

Autonomic Nerve Block

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Lanette Friesen-Waldner, Ph.D

CONTACT

5196466100; lanette.friesen-waldner@sjhc.london.on.ca

Cristian Dihel, MD

CONTACT

cristian.dihel@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MHM, FRCSC Associate Professor, Rhinology and Anterior Skull Base Surgery

Model Details: Double-Blinded, Placebo-Controlled Randomized Clinical Trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 26, 2023
• Study Start: February 15, 2024
• Primary Completion: December 24, 2025
• Study Completion: May 15, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)