Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transnasal sphenopalatine ganglion block.
- Who it may be relevant to
- Registry conditions: SAH (Subarachnoid Hemorrhage), Headache. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 product Transnasal 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.
Primary outcome measures
- Numerical pain rating scale [Time frame: From enrollment until ICU discharge, up to 14 days]
Secondary outcome measures (1)
- Morphine milligram equivalents (MME) [Time frame: From enrollment to hospital discharge, up to 14 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC Davis Medical Center — Sacramento
Identifiers
NCT: NCT06621329 · 2160233