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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; SAH (Subarachnoid Hemorrhage)
• Intervention / Treatment: Combination product: Transnasal sphenopalatine ganglion block

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Janice Wang-Polagruto, PhD, CCRP; Phone Number: 916-551-3244; Email: jfwang@ucdavis.edu
• Study Contact Backup: Name: Ryan Martin, MD; Phone Number: 916-734-4300; Email: rymartin@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
      • Contact: Christine Picinich, AGACNP-BC, MS; Phone Number: 7075368452; Email: cpicinich@ucdavis.edu
      • Contact: Christine Picinich
      • Principal Investigator: Christine Picinich, AGACNP-BC, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Combination product: 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.; Other Names: peripheral nerve block; SPG block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine milligram equivalents (MME)	Total Morphine milligram equivalents per ICU day will be collected for up to 14 days. Total morphine milligram equivalents will also be collected on the day of hospital discharge. Total morphine milligram equivalents for ICU course and total morphine milligram equivalents on day of discharge will be compared between the two arms.	From enrollment to hospital discharge, up to 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasospasm	Incidence of vasospasm during ICU course will be collected for both arms.	From enrollment to ICU discharge, up to 14 days
Incidence of adverse events related to SPG block procedure	Adverse reactions or events related to the SPG block procedure will be tracked and documented.	From enrollment to hospital discharge, up to 14 days

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Agnes Marshall Walker Foundation
• Investigators: Principal Investigator: Christine Picinich, MS, AGACNP-BC, CCRN, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: subarachnoid hemorrhage; headache; sphenopalatine ganglion; aSAH; peripheral nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Subarachnoid Hemorrhage
• Other Study ID Numbers: 2160233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes