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NCT06621329PHASE2, PHASE3Recruiting

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

University of California, Davis

Start Date

10/17/2024

Completion Date

10/1/2026

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.

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.

Eligibility Criteria

Age Range: 18 years to 100 years

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

Interventions

COMBINATION_PRODUCT

Transnasal sphenopalatine ganglion block

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Conditions

SAH (Subarachnoid Hemorrhage)Headache

Locations

UC Davis Medical Center

Sacramento, California 95817

United States