Меню
Набор скоро начнётся NCT06554067

Effects of tDCS and VNS on Postoperative Analgesia

Без фазы С лечением Acute Postoperative Pain

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: Active transcranial direct current stimulation, Active vagus nerve stimulation, Sham transcranial direct current stimulation, Sham vagus nerve stimulation.
Кому может быть актуально
Состояния в реестре: Acute Postoperative Pain. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery. Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes. Patients will be divided in the following comparison groups: * Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. * Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. * Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. * Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Подробное описание

Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia.

This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:

* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. * Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. * Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. * Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.

Вмешательства

  • Устройство Active transcranial direct current stimulation
    Ten minutes of active transcranial direct current stimulation
  • Устройство Active vagus nerve stimulation
    Ten minutes of active vagus nerve stimulation
  • Другое Sham transcranial direct current stimulation
    Ten minutes of sham tDCS
  • Другое Sham vagus nerve stimulation
    Ten minutes of sham VNS

Первичные конечные точки

  • Pain levels using Numerical Rating Scale [Срок оценки: Immediately before the intervention and immediately after the intervention.]
  • Pain levels using the Verbal Rating Scale [Срок оценки: Immediately before the intervention and immediately after the intervention.]
Вторичные конечные точки (4)
  • Vital Signs: Blood pressure. [Срок оценки: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.]
  • Vital Signs: Heart rate [Срок оценки: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.]
  • Opioid consumption [Срок оценки: 24 hours after surgery]
  • Time from surgery to discharge [Срок оценки: From the date of the patient's surgery until the day of the discharge, up to 2 month.]

Критерии участия

Критерии включения

  • Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia

Критерии исключения

  • cardiac bradyarrhythmia: taking beta-blockers;
  • patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
  • pregnancy
  • history of epilepsy or seizures.
  • patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06554067 · AAAV2033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗