Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 2

Conditions: Ischemic Stroke; Stroke; Headache

Treatments: Drug: Placebo; Drug: Liquid Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05365880

138103

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Liquid Lidocaine

Experimental group

Description:

The investigational treatment is 1.5 mL of aqueous 2% lidocaine.

Treatment:

Drug: Liquid Lidocaine

Sham Placebo

Placebo Comparator group

Description:

The placebo arm is 1.5mL of aqueous of saline.

Treatment:

Drug: Placebo