Headache, Ischemic Stroke, Stroke
Conditions
Keywords
Post-Stroke Headache, Sphenopalatine Ganglion (SPG) block
Brief summary
Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.
Detailed description
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.
Interventions
DRUGLiquid Lidocaine
The investigational treatment is 2 mL of aqueous 2% lidocaine.
DRUGPlacebo
The active placebo comparator will be provided to participant.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older; 2. hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician; 3. 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
1. Previous treatment with SPG Block for post-stroke headache 2. history of prophylactic medication use for headache or migraine; 3. pregnant at time of stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Migraine Headaches During Treatment Phase | 90 days | Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | 90 days | The quantitative scale ranges from 0 to 10, with 0 meaning no headache at all and 10 meaning the worst possible headache. |
| Adverse effect | 90 days | Bitter taste, nose bleeding, throat discomfort |
Countries
United States
Outcome results
None listed