A Phase 2/3 interventional study of Transnasal sphenopalatine ganglion block in SAH (Subarachnoid Hemorrhage) and Headache, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of California, Davis · Phase 2/3, Interventional, and Treatment
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.
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.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 40 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Exclusion Criteria:
Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache.
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.
Also known as: SPG block, peripheral nerve block
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.
Time frame: From enrollment until ICU discharge, up to 14 days
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.
Time frame: From enrollment to hospital discharge, up to 14 days
Vasospasm
Incidence of vasospasm during ICU course will be collected for both arms.
Time frame: 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.
Time frame: From enrollment to hospital discharge, up to 14 days
Plan to share: Undecided
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