Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
Overview
- Phase
- Phase 2
- Intervention
- Liquid Lidocaine
- Conditions
- Headache
- Sponsor
- University of Utah
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Number of Migraine Headaches During Treatment Phase
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Liquid Lidocaine
The investigational treatment is 1.5 mL of aqueous 2% lidocaine.
Intervention: Liquid Lidocaine
Sham Placebo
The placebo arm is 1.5mL of aqueous of saline.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Number of Migraine Headaches During Treatment Phase
Time Frame: 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 Outcomes
- Numeric Pain Rating Scale(90 days)
- Adverse effect(90 days)