Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055270
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-09-22
Brief Title:
Stellate Ganglion Block with Lidocaine for the Treatment of COVID-19-Induced Parosmia
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Stellate Ganglion Block with Lidocaine for the Treatment of COVID-19-Induced Parosmia Double-Blinded Placebo-Controlled Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stella
Brief Summary:
Chronic olfactory dysfunction both hyposmia and parosmia from the COVID-19 pandemic is a growing public health crisis affecting up to 12 million people in the United States Olfactory dysfunction significantly impacts ones quality of life by decreasing the enjoyment of foods creating environmental safety concerns and affecting ones 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 communitys 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
Recent research suggests that parosmia more so than hyposmia can increase anxiety depression and even suicidal ideation While the pandemic has advanced the scientific communitys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None