Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
- Conditions
- SAH (Subarachnoid Hemorrhage)Headache
- Interventions
- Combination Product: Transnasal sphenopalatine ganglion block
- Registration Number
- NCT06621329
- Lead Sponsor
- University of California, Davis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transnasal SPG Block and Standard of Care Medications Transnasal sphenopalatine ganglion block 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
UC Davis Medical Center
🇺🇸Sacramento, California, United States