Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Utah System of Higher Education (USHE) logo

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

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

Trial contacts and locations

1

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Central trial contact

Seniha Ozudogru, MD; Ka-Ho Wong

Data sourced from clinicaltrials.gov

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