Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Study Overview
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Brief Summary
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Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.

Detailed Description
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The purpose of this study is to determine if sphenopalatine ganglion (SPG) block is a safe and effective treatment for acute post-stroke headache. Current literature lacks randomized controlled studies regarding the efficacy of different treatment modalities for acute post-stroke headache; additionally, there are no evidence-based guidelines for the treatment of acute post-stroke headache. Sphenopalatine ganglion block is a non-invasive procedure where an anesthetic agent is injected into the nares, reaching the SPG to relieve pain and autonomic features. This treatment has been effective in a variety of headache types but to our knowledge has not been studied in acute post-stroke headache.

Official Title
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Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Conditions
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Headache, Stroke, Ischemic Stroke

Intervention / Treatment
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* Drug: Liquid Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older; hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician; meets at least one of the following International Classification of Headache Disorder-3 (ICHD-3) criteria: 6.1.1.1 (Acute Headache Attributed to Ischemic Stroke), 6.2.1 (Headache attributed to non-traumatic intracerebral hemorrhage), 6.2.2 (Acute headache attributed to non-traumatic subarachnoid hemorrhage); received at least one medication for headache during hospitalization. Exclusion Criteria: Previous treatment with SPG Block for post-stroke headache history of prophylactic medication use for headache or migraine; pregnant at time of stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid Lidocaine<br>The investigational treatment is 1.5 mL of aqueous 2% lidocaine. | Drug: Liquid Lidocaine<br>* The investigational treatment is 2 mL of aqueous 2% lidocaine.<br>|
| Placebo Comparator: Sham Placebo<br>The placebo arm is 1.5mL of aqueous of saline. | Drug: Placebo<br>* The active placebo comparator will be provided to participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Migraine Headaches During Treatment Phase | Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | The quantitative scale ranges from 0 to 10, with 0 meaning no headache at all and 10 meaning the worst possible headache. | 90 days | 
| Adverse effect | Bitter taste, nose bleeding, throat discomfort | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Stroke Headache, Sphenopalatine Ganglion (SPG) block