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

NCT06621329 | Recruiting Phase 2 FDA Device

• 1 other identifier: 2160233
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

SAH (Subarachnoid Hemorrhage); Headache

Keywords

aSAH; peripheral nerve block; sphenopalatine ganglion; subarachnoid hemorrhage; headache

Outcome Measures

Primary Outcomes (1)

• Numerical pain rating scale

  Pain scores will be obtained at regular intervals to compare pain control between the two arms. Pain scores will be collected multiple times throughout each ICU day, up to ICU day 14.

  From enrollment until ICU discharge, up to 14 days

Secondary Outcomes (1)

• Morphine milligram equivalents (MME)

  From enrollment to hospital discharge, up to 14 days

Other Outcomes (2)

• Vasospasm

  From enrollment to ICU discharge, up to 14 days

• Incidence of adverse events related to SPG block procedure

  From enrollment to hospital discharge, up to 14 days

Study Arms (2)

Standard of Care Medications for Headache

NO INTERVENTION

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

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.

Combination Product: Transnasal sphenopalatine ganglion block

Interventions

Transnasal sphenopalatine ganglion block 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.

Also known as: SPG block, peripheral nerve block

Transnasal SPG Block and Standard of Care Medications

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Agnes Marshall Walker Foundation: collaborator

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Christine Picinich, MS, AGACNP-BC, CCRN

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janice Wang-Polagruto, PhD, CCRP

CONTACT

916-551-3244; jfwang@ucdavis.edu

Ryan Martin, MD

CONTACT

916-734-4300; rymartin@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both arms will receive standard of care medications for headache management. The intervention group will receive an SPG block at a specific threshold defined in the study protocol.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)