Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05365880

Collaborator

(none)

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Headache Stroke Ischemic Stroke	Drug: Liquid Lidocaine Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Actual Study Start Date :

Mar 23, 2022

Anticipated Primary Completion Date :

Mar 22, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liquid Lidocaine The investigational treatment is 1.5 mL of aqueous 2% lidocaine.	Drug: Liquid Lidocaine The investigational treatment is 2 mL of aqueous 2% lidocaine.
Placebo Comparator: Sham Placebo The placebo arm is 1.5mL of aqueous of saline.	Drug: Placebo The active placebo comparator will be provided to participant.

Arm

Intervention/Treatment

Experimental: Liquid Lidocaine

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

Drug: Liquid Lidocaine

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

Placebo Comparator: Sham Placebo

The placebo arm is 1.5mL of aqueous of saline.

Drug: Placebo

The active placebo comparator will be provided to participant.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.