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

NCT ID: NCT06621329

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2026-10-31

Brief Summary

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.

Detailed 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.

Conditions

SAH (Subarachnoid Hemorrhage); Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Medications for Headache

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Transnasal SPG Block and Standard of Care Medications

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.

Group Type: EXPERIMENTAL

Transnasal sphenopalatine ganglion block

Intervention Type: COMBINATION_PRODUCT

Transnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone.

Interventions

Transnasal sphenopalatine ganglion block

Transnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

SPG block; peripheral nerve block

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agnes Marshall Walker Foundation

UNKNOWN

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Picinich, MS, AGACNP-BC, CCRN

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Medical Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Janice Wang-Polagruto, PhD, CCRP

Role: CONTACT

jfwang@ucdavis.edu

916-551-3244

Ryan Martin, MD

Role: CONTACT

rymartin@ucdavis.edu

916-734-4300

Facility Contacts

Christine Picinich, AGACNP-BC, MS

Role: primary

cpicinich@ucdavis.edu

7075368452

Christine Picinich

Role: backup

Other Identifiers

2160233

Identifier Type: -

Identifier Source: org_study_id