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Набор скоро начнётся NCT07721818

The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy

Фаза IV С лечением Surgical Stress Response Total Thyroidectomy Saliva Collection Cervical Plexus Block

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: Ultrasound guided bilateral intermediate cervical plexus block.
Кому может быть актуально
Состояния в реестре: Surgical Stress Response, Total Thyroidectomy, Saliva Collection, Cervical Plexus Block. 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 →

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Обзор

The aim of this study is to evaluate how an ultrasound-guided bilateral intermediate cervical plexus block affects the surgical stress response in individuals undergoing total thyroidectomy. The primary objective is to quantify this physiological response through the analysis of specific stress and inflammatory biomarkers collected from the participants' saliva. The clinical trial will encompass a total of 48 patients, randomized equally into two distinct cohorts of 24 participants each. The control group will undergo standard total intravenous anesthesia (TIVA), whereas the experimental group will receive the bilateral intermediate cervical plexus block in combination with the TIVA protocol. It is hypothesized that integrating this regional nerve block with total intravenous anesthesia will significantly attenuate the surgical stress response, evidenced by a reduction in salivary biomarker concentration, compared to utilizing TIVA alone during thyroid surgery. Validating this hypothesis would offer robust scientific evidence to advocate for the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic practices for total thyroidectomy. Ultimately, this approach aims to minimize perioperative stress and facilitate a more rapid postoperative recovery for patients.

Вмешательства

  • Процедура Ultrasound guided bilateral intermediate cervical plexus block
    Following the induction of general anesthesia in the study group, an ultrasound-guided bilateral intermediate cervical plexus block will be performed. The cervical plexus is visualized on the screen as a small cluster of hypoechoic nodules beneath the posterolateral border of the sternocleidomastoid muscle and immediately above the prevertebral fascia. After sterile preparation, a 22-gauge needle is inserted under ultrasound guidance in a lateromedial direction. The needle tip is positioned wit

Первичные конечные точки

  • Salivary IL-6 Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
  • Salivary Cortisol Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
  • Salivary Alpha-amylase Activity [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
Вторичные конечные точки (7)
  • Total Intraoperative Sufentanyl Consumption [Срок оценки: Intraoperative period]
  • Total Postoperative Analgetics consumption [Срок оценки: During the first 24 hours after the completion of surgery]
  • Time to Rescue Analgesia [Срок оценки: During the first 24 hours after the completion of surgery]
  • Hemodynamic Stability (heart rate) [Срок оценки: Intraoperative period and during the first 24 hours after the completion of surgery]
  • Postoperative Sedation Level [Срок оценки: During the first 4 hours after the completion of surgery]
  • Postoperative Nausea and Vomiting [Срок оценки: During the first 24 hours after the completion of surgery]
  • Hemodynamic Stability (blood pressure) [Срок оценки: Intraoperative period and during the first 24 hours after the completion of surgery]

Критерии участия

Критерии включения

  • ASA I or ASA II
  • euthyroid status
  • signed informed consent

Критерии исключения

  • patients who refuse to sign the informed consent form
  • infection at the block injection site
  • hypersensitivity or contraindications to the medication used in the study
  • hypo/hyperthyroidism at the time of surgery
  • presence of substernal goiter
  • additional surgical interventions during the procedure
  • history of previous neck surgery or radiation
  • coagulopathy
  • uncontroled respiratory disease
  • diabetes mellitus
  • autoimune disease
  • chronic corticosteroid therapy
  • smokers
  • pregnant women

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07721818 · 0119-04-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗