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Набор скоро начнётся NCT07669688

Pulse Wave Transit Time After Infraclavicular Block

Наблюдательное Infraclavicular Brachial 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 infraclavicular brachial plexus block.
Кому может быть актуально
Состояния в реестре: Infraclavicular Brachial Plexus Block. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Time-Dependent Changes in Pulse Wave Transit Time Following Infraclavicular Block: A Non-Invasive Assessment of Sympathetic Blockade

Обзор

This prospective observational study aims to evaluate the time-dependent changes in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT is a non-invasive hemodynamic parameter reflecting vascular tone and sympathetic nervous system activity. Patients undergoing upper extremity surgery under infraclavicular block will be monitored using standard perioperative monitoring devices. PWTT measurements will be obtained before and after block placement at predefined time intervals. Secondary outcomes will include perfusion index, skin temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation. The study seeks to determine whether PWTT can serve as an objective and non-invasive marker of sympathetic blockade following infraclavicular block.

Подробное описание

Regional anesthesia success is traditionally assessed using sensory and motor block evaluation methods that rely on patient cooperation and subjective responses to external stimuli. However, these methods may be difficult to apply in sedated, uncooperative, or communication-impaired patients. Therefore, objective and non-invasive indicators of sympathetic blockade have gained increasing interest in regional anesthesia practice.

Pulse Wave Transit Time (PWTT) is defined as the time interval between the R-wave on the electrocardiogram and the arrival of the corresponding pulse wave detected by a peripheral pulse oximeter. PWTT reflects vascular tone, arterial compliance, and hemodynamic status. Sympathetic blockade induced by peripheral nerve blocks results in vasodilation and reduced vascular resistance, potentially leading to measurable changes in PWTT. Previous studies have demonstrated the utility of objective parameters such as perfusion index, skin temperature, blood flow measurements, and PWTT in assessing block success. However, data regarding the temporal changes of PWTT following infraclavicular brachial plexus block remain limited.

The primary objective of this prospective observational study is to investigate the time-dependent changes in PWTT after ultrasound-guided infraclavicular brachial plexus block. The study will be conducted in patients undergoing upper extremity surgery under infraclavicular block at Sakarya Training and Research Hospital.

Patients scheduled to receive infraclavicular block as part of their routine clinical care will be enrolled after providing informed consent. The block procedure is not performed for research purposes and represents standard clinical practice. Following block administration, PWTT values will be recorded from the blocked extremity using standard monitoring equipment. Measurements will be obtained before block placement and at 0, 5, 10, 15, and 20 minutes after block completion. Baseline PWTT measurements will also be obtained from the contralateral upper extremity.

Secondary outcome measures will include perfusion index, skin temperature of both upper extremities, heart rate, non-invasive blood pressure, respiratory rate, and oxygen saturation. Demographic and clinical data will also be recorded.

All measurements will be collected according to a predefined protocol using standardized monitoring equipment. Since PWTT is an objective device-derived parameter, observer dependency is expected to be minimal. Data collection personnel will be separated from the clinician performing the block whenever feasible to reduce measurement bias. All collected data will be anonymized prior to statistical analysis.

This study is designed as a single-center, prospective observational investigation without randomization or intervention beyond routine clinical care. The findings may contribute to the development of PWTT as a practical, objective, and non-invasive marker of sympathetic blockade following infraclavicular brachial plexus block.

Вмешательства

  • Процедура Ultrasound-guided infraclavicular brachial plexus block
    Ultrasound-guided infraclavicular brachial plexus block will be performed as part of routine clinical anesthesia practice for upper extremity surgery. Local anesthetic will be administered according to standard institutional protocols. No additional or experimental drug or procedure will be applied for research purposes. Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be recorded before and after block placement at predefined time intervals.

Первичные конечные точки

  • Change in Pulse Wave Transit Time [Срок оценки: 20 minutes after infraclavicular block]
Вторичные конечные точки (3)
  • Perfusion Index [Срок оценки: 20 minutes after infraclavicular block]
  • Skin Temperature [Срок оценки: 20 minutes after infraclavicular block]
  • oxygen saturation [Срок оценки: 20 minutes after infraclavicular block]

Критерии участия

Критерии включения

  • Patients undergoing elective upper extremity hand surgery
  • 18 - 65 years
  • ASA I
  • No coagulopathy, thrombocytopenia, coagulation disorders
  • Patients who provide informed consent to participate in the study

Критерии исключения

  • History of drug allergy relevant to study procedures or local anesthetics
  • Body mass index (BMI) ≥ 30 kg/m²
  • Body weight < 40 kg
  • Age < 18 years or > 65 years
  • History of significant cardiac disease (e.g., arrhythmia, conduction abnormalities)
  • Coagulopathy (INR > 1.5 or platelet count < 100,000/mm³)
  • Pregnancy or lactation
  • Infection at the site of peripheral nerve block
  • ASA II-IV
  • Failed block or motor block duration exceeding 30 minutes
  • Patients reporting pain (NRS ≥ 3), due to potential influence on sympathetic activity
  • Chronic opioid use

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sakarya University-Anesthesiology and Reanimation Department — Sakarya

Публикации

  • Choi EJ, Lim JA, Choi CH, Kim DH, Jo S, Kim J. Changes in pulse wave transit time variability after interscalene brachial plexus block placement. Korean J Anesthesiol. 2026 Feb;79(1):82-94. doi: 10.4097/kja.24861. Epub 2025 May 21. PMID 40398868

Идентификаторы

NCT: NCT07669688 · SAU-ANE-BA-04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗