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NCT Number: NCT06621329

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Christine Picinich

CONTACT

Christine Picinich, AGACNP-BC, MS

CONTACT

[email protected]

7075368452

Christine Picinich, AGACNP-BC, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SPG block, peripheral nerve block

Primary outcomes

  1. Numerical pain rating scale

    Time frame: From enrollment until ICU discharge, up to 14 days

    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.

Secondary outcomes

  1. Morphine milligram equivalents (MME)

    Time frame: From enrollment to hospital discharge, up to 14 days

    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.

Other outcomes

  1. Vasospasm

    Time frame: From enrollment to ICU discharge, up to 14 days

    Incidence of vasospasm during ICU course will be collected for both arms.

  2. Incidence of adverse events related to SPG block procedure

    Time frame: From enrollment to hospital discharge, up to 14 days

    Adverse reactions or events related to the SPG block procedure will be tracked and documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Janice Wang-Polagruto, PhD, CCRP

CONTACT

[email protected]

916-551-3244

Ryan Martin, MD

CONTACT

[email protected]

916-734-4300

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Agnes Marshall Walker Foundation

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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