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Trial Title:
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
NCT ID:
NCT06621329
Condition:
SAH (Subarachnoid Hemorrhage)
Headache
Conditions: Official terms:
Ganglion Cysts
Subarachnoid Hemorrhage
Hemorrhage
Headache
Conditions: Keywords:
aSAH
peripheral nerve block
sphenopalatine ganglion
subarachnoid hemorrhage
headache
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Transnasal sphenopalatine ganglion block
Description:
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.
Arm group label:
Transnasal SPG Block and Standard of Care Medications
Other name:
SPG block
Other name:
peripheral nerve block
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UC Davis Medical Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Picinich, AGACNP-BC, MS
Phone:
7075368452
Email:
cpicinich@ucdavis.edu
Contact backup:
Last name:
Christine Picinich
Investigator:
Last name:
Christine Picinich, AGACNP-BC, MS
Email:
Principal Investigator
Start date:
October 2024
Completion date:
October 2026
Lead sponsor:
Agency:
University of California, Davis
Agency class:
Other
Collaborator:
Agency:
Agnes Marshall Walker Foundation
Agency class:
Other
Source:
University of California, Davis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06621329
