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Набор скоро начнётся NCT07092891

Early Detection of Supraclavicular Brachial Plexus Block Failure Using Infrared Thermography and Perfusion Index

Без фазы С лечением Regional Anaesthsia Brachial Plexus Blocks

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 Supraclavicular Block, Bupivacaine Hydrochloride 0.5 % Injectable Solution, Ultrasound, Infrared Thermography Camera.
Кому может быть актуально
Состояния в реестре: Regional Anaesthsia, Brachial Plexus Blocks. Базовые параметры: 18 лет — 70 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 →
Официальное название

Early Detection of Supraclavicular Brachial Plexus Block Failure Using Infrared Thermography and Perfusion Index: Randomized Double-Blind Controlled Study

Обзор

Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary. Emerging non-invasive monitoring technologies offer promising alternatives for the early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases due to sympathetic nerve blockade-induced vasodilation.

Подробное описание

Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary.

Emerging non-invasive monitoring technologies offer promising alternatives for early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases with sympathetic nerve blockade-induced vasodilation. Perfusion Index (PI), derived from pulse oximetry, reflects peripheral perfusion and also rises as vascular tone decreases following a successful nerve block. Both IRT and PI provide quantifiable, real-time physiological markers of sympathetic and circulatory changes that precede full sensory or motor blockade. Although several studies support their individual utility, there is limited evidence on their combined predictive value or their integration into routine clinical practice. Further investigation is needed to validate their role in enhancing the accuracy and timeliness of block assessment.

Вмешательства

  • Процедура Ultrasound-Guided Supraclavicular Block
    Ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear ultrasound probe-real-time visualization of the brachial plexus for precise anesthetic delivery.
  • Препарат Bupivacaine Hydrochloride 0.5 % Injectable Solution
    30 mL used for supraclavicular brachial plexus block
  • Устройство Ultrasound
    Imaging for block placement
  • Устройство Infrared Thermography Camera
    Skin temperature monitoring
  • Устройство Pulse Oximeter
    Perfusion Index monitoring

Первичные конечные точки

  • Change in Skin Temperature (°C) Measured by Infrared Thermography From Baseline to 10 Minutes Post-block. [Срок оценки: Baseline, 5, and 10 minutes post-injection]
  • Change in Perfusion Index From Baseline to 10 Minutes Post-block [Срок оценки: Baseline, 5, and 10 minutes post-injection]
Вторичные конечные точки (1)
  • Correlation Between Changes in Skin Temperature and Perfusion Index With Sensory and Motor Block Scores at 20 Minutes [Срок оценки: 20 minutes post-injection]

Критерии участия

Критерии включения

  • Adults aged 18-70 years
  • ASA Physical Status I-III

Критерии исключения

  • General
  • Coagulopathy
  • Allergy to local anesthetics
  • Special
  • Neurological deficits in the affected limb
  • Peripheral vascular disease or Raynaud's phenomenon
  • Infections or skin lesions at the site of injection
  • Use of a tourniquet

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Gamal M, Hasanin A, Adly N, Mostafa M, Yonis AM, Rady A, Abdallah NM, Ibrahim M, Elsayad M. Thermal Imaging to Predict Failed Supraclavicular Brachial Plexus Block: A Prospective Observational Study. Local Reg Anesth. 2023 Jun 9;16:71-80. doi: 10.2147/LRA.S406057. eCollection 2023. PMID 37323293
  • Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166. PMID 28854539

Идентификаторы

NCT: NCT07092891 · Brachial Plexus Block Failure

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗