Actively Recruiting
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Led by University of California, Davis · Updated on 2025-11-26
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
A
Agnes Marshall Walker Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of a transnasal sphenopalatine ganglion (SPG) block to treat headaches associated with acute subarachnoid hemorrhage (aSAH). This randomized controlled pilot study aims to evaluate whether adding the SPG block to standard pain medication reduces headache severity and decreases opioid use during hospitalization and after discharge. The study involves adult patients with secured aneurysms who can communicate their pain scores. Participants are divided into two groups: one receiving standard headache care medications and the other receiving the same medications plus the transnasal SPG block. The SPG block is delivered through the nasal passages using a needleless Tx360 device, with medications including 0.75% bupivacaine, sometimes combined with dexamethasone. This intervention is given when specific pain thresholds are met according to the study protocol. During the study, participants' pain levels are measured using a numerical pain rating scale from enrollment until discharge from the intensive care unit, up to 14 days. Opioid use is tracked from enrollment until hospital discharge. Safety monitoring is conducted to watch for any adverse effects. Individual participation lasts up to four weeks within the approximately 24-month study timeline.
CONDITIONS
Brief Title
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute subarachnoid hemorrhage
- Age greater than 18 years
- Secured aneurysm
- Ability to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker
- Patient or surrogate decision maker available to provide consent
You will not qualify if you...
- Younger than 18 years
- Unsecured aneurysm
- Pregnant or lactating
- Prisoner status
- 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
- Unable to consent and no available surrogate decision maker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days or until ICU discharge
Participants receive standard care medications for headache. Some participants also receive a transnasal sphenopalatine ganglion block using the Tx360 device when a predefined threshold is met.
Daily visits while in ICU for up to 14 days
Trial Site Locations
Total: 1 location
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
J
Janice Wang-Polagruto, PhD, CCRP
R
Ryan Martin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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