Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Phase 2

Withdrawn

• Conditions: Headache; Ischemic Stroke; Stroke
• Interventions: Drug: Placebo; Drug: Liquid Lidocaine

• Registration Number: NCT05365880
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-03-22
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Placebo	Placebo	The placebo arm is 1.5mL of aqueous of saline.
Liquid Lidocaine	Liquid Lidocaine	The investigational treatment is 1.5 mL of aqueous 2% lidocaine.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States