Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• Numerical pain rating scale [Срок оценки: From enrollment until ICU discharge, up to 14 days]

Вторичные конечные точки (1)

• Morphine milligram equivalents (MME) [Срок оценки: From enrollment to hospital discharge, up to 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UC Davis Medical Center — Sacramento

Идентификаторы

NCT: NCT06621329 · 2160233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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