Clinical trial NCT06621329: Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Official title: Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: SAH (Subarachnoid Hemorrhage)
Headache
Keywords: aSAH
peripheral nerve block
sphenopalatine ganglion
subarachnoid hemorrhage
headache
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Agnes Marshall Walker Foundation
First posted: 2024-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both arms will receive standard of care medications for headache management. The intervention group will receive an SPG block at a specific threshold defined in the study protocol.
Primary purpose: TREATMENT

Brief summary: The study titled \&#34;Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\&#34; 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: 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

Primary outcomes:
measure: Numerical pain rating scale
timeFrame: From enrollment until ICU discharge, up to 14 days
Secondary outcomes:
measure: Morphine milligram equivalents (MME)
timeFrame: From enrollment to hospital discharge, up to 14 days
Other outcomes:
measure: Vasospasm
timeFrame: From enrollment to ICU discharge, up to 14 days
measure: Incidence of adverse events related to SPG block procedure
timeFrame: From enrollment to hospital discharge, up to 14 days
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Christine Picinich, MS, AGACNP-BC, CCRN
role: PRINCIPAL_INVESTIGATOR
References: