Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache

University of California (UC) Davis

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: SAH (Subarachnoid Hemorrhage); Headache

Treatments: Combination Product: Transnasal sphenopalatine ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT06621329

2160233

Details and patient eligibility

About

The study titled "Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache" is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (aSAH). The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.

Full description

The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. It involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. Those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded.

Participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block. The SPG block is administered using a needleless device called the Tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways.

Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block. The study also includes safety monitoring to track any adverse effects from the intervention. The entire study spans approximately 24 months, with individual participation lasting up to four weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute subarachnoid hemorrhage
• Age greater than 18 years
• Secured aneurysm
• Patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision
• maker
• Patient or surrogate decision maker is available to consent

Exclusion criteria

• Less than 18 years old
• Unsecured aneurysm
• Pregnant or lactating
• Prisoner
• Unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker
• Nasal or facial trauma or surgery within the last three months
• Allergy to lidocaine, bupivacaine, or dexamethasone
• Patient is unable to consent and no available surrogate decision maker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard of Care Medications for Headache

No Intervention group

Description:

Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache.

Transnasal SPG Block and Standard of Care Medications

Experimental group

Description:

Intervention arm participants will receive standard of care medications, as defined in a headache protocol, with the addition of transnasal SPG blocks when a predefined threshold is met per the study protocol.

Treatment:

Combination Product: Transnasal sphenopalatine ganglion block