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Идёт набор NCT06069791

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

Фаза I С лечением Post-Traumatic Headache

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bupivacaine Injection.
Кому может быть актуально
Состояния в реестре: Post-Traumatic Headache. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1

Обзор

The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.

Подробное описание

Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted.

Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden.

The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).

Вмешательства

  • Препарат Bupivacaine Injection
    subcutaneous injection around bilateral greater occipital nerves

Первичные конечные точки

  • Acute sensation felt during injection: quality [Срок оценки: During injection]
  • Acute sensation felt during injection: intensity [Срок оценки: During injection]
  • Paresthesia felt after injection: quality [Срок оценки: From the time of injection to 1 week after injection]
  • Paresthesia felt after injection: intensity [Срок оценки: From the time of injection to 1 week after injection]
  • Paresthesia felt after injection: distribution [Срок оценки: From the time of injection to 1 week after injection]
  • Paresthesia felt after injection: duration [Срок оценки: From the time of injection to 1 week after injection]
Вторичные конечные точки (1)
  • Adverse events [Срок оценки: From the first injection to two weeks after the last injection]

Критерии участия

Критерии включения

  • United States Military Veterans within VA Connecticut Healthcare System
  • Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury)
  • At least two headache days per week
  • MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years
  • Review of MRI and the medical record does not reveal another source for headache

Критерии исключения

  • Skull defect
  • Other contraindication to bupivacaine
  • Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine
  • Instruction from clinician to avoid amide anesthetics, such as lidocaine
  • Pregnant or lack of adequate birth control

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • VA Connecticut Healthcare System — West Haven

Идентификаторы

NCT: NCT06069791 · 1656679

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗