SAH (Subarachnoid Hemorrhage), Headache
Conditions
Keywords
aSAH, peripheral nerve block, sphenopalatine ganglion, subarachnoid hemorrhage, headache
Brief 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.
Interventions
COMBINATION_PRODUCTTransnasal 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.
Sponsors
Agnes Marshall Walker Foundation
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical pain rating scale | From enrollment until ICU discharge, up to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine milligram equivalents (MME) | From enrollment to hospital discharge, up to 14 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vasospasm | From enrollment to ICU discharge, up to 14 days | Incidence of vasospasm during ICU course will be collected for both arms. |
| Incidence of adverse events related to SPG block procedure | From enrollment to hospital discharge, up to 14 days | Adverse reactions or events related to the SPG block procedure will be tracked and documented. |
Countries
United States
Contacts
Primary ContactJanice Wang-Polagruto, PhD, CCRP
Backup ContactRyan Martin, MD
Outcome results
None listed