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Идёт набор NCT07548567

A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery

Без фазы С лечением Tourniquet Hypertension

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: Femoral artery block - short-axis, Femoral artery block - long-axis, Normal saline injection (control).
Кому может быть актуально
Состояния в реестре: Tourniquet Hypertension. 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
Греция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Turning the Probe, Changing the View: A Novel Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery: A Prospective, Randomized, Double-Blind Controlled Trial

Обзор

This is a prospective, randomized, double-blind controlled trial evaluating an ultrasound-guided femoral artery block (FAB) using a long-axis in-plane approach compared with a short-axis approach and a control group. The study will include adult patients (ASA I-III) undergoing below-the-knee fracture surgery with tourniquet application. All patients will receive standardized anesthesia including sciatic nerve block and total intravenous anesthesia. Participants will be randomized into three groups: short-axis FAB, long-axis FAB, or control (saline injection). The primary aim is to assess the effectiveness of the long-axis FAB in reducing tourniquet-induced hypertension. Secondary outcomes include hemodynamic stability, analgesic requirements, pain scores, block characteristics, and procedural performance metrics.

Подробное описание

Tourniquet application during lower limb orthopedic surgery is associated with significant hemodynamic responses, including pain and tourniquet-induced hypertension (TH), which may increase perioperative cardiovascular risk. Femoral artery block (FAB) is a novel ultrasound-guided regional anesthesia technique targeting the perivascular sympathetic plexus surrounding the femoral artery to attenuate these responses.

Previous studies have described FAB using a short-axis in-plane ultrasound approach. This study proposes a novel long-axis in-plane ultrasound technique, hypothesizing that longitudinal visualization of the femoral artery may improve anatomical alignment with perivascular sympathetic structures, resulting in more effective sympathetic blockade, improved safety, and enhanced clinical efficacy.

This is a prospective, randomized, double-blind controlled trial including adult patients (ASA I-III) scheduled for below-the-knee fracture surgery requiring tourniquet application for at least 45 minutes. After informed consent and baseline assessment, patients will be randomized into three groups: (1) short-axis FAB with ropivacaine, (2) long-axis FAB with ropivacaine, and (3) control group receiving normal saline injection.

All patients will receive standardized anesthetic management including sciatic nerve block at the popliteal level and total intravenous anesthesia using propofol and remifentanil via Target-Controlled Infusion (TCI) under BIS monitoring. Hemodynamic variables (blood pressure and heart rate) will be recorded at predefined intraoperative and postoperative time points. Tourniquet-induced hypertension will be defined as a \>30% increase in systolic blood pressure from baseline.

Secondary outcomes include intraoperative opioid and vasopressor requirements, incidence of femoral and saphenous nerve spread, procedural performance metrics (imaging and needling time), postoperative pain scores (VAS), and opioid consumption in the recovery unit.

Data will be analyzed using repeated-measures and comparative statistical models to evaluate differences between groups over time and between interventions.

Вмешательства

  • Процедура Femoral artery block - short-axis
    Ultrasound-guided femoral artery block using short-axis in-plane technique with 10 mL ropivacaine 0.5%.
  • Процедура Femoral artery block - long-axis
    Ultrasound-guided femoral artery block using long-axis in-plane technique with 10 mL ropivacaine 0.5%.
  • Другое Normal saline injection (control)
    Ultrasound-guided femoral artery injection using 10 mL 0.9% normal saline.

Первичные конечные точки

  • Incidence of tourniquet-induced hypertension [Срок оценки: From tourniquet inflation to 90 minutes intraoperatively]
Вторичные конечные точки (10)
  • Heart rate [Срок оценки: From tourniquet inflation to 90 minutes intraoperatively]
  • Intraoperative esmolol consumption [Срок оценки: Intraoperative period]
  • Intraoperative remifentanil consumption [Срок оценки: Intraoperative period]
  • Postoperative pain score (VAS) [Срок оценки: 0-60 minutes postoperative]
  • Morphine consumption in recovery unit [Срок оценки: 0-60 minutes postoperative]
  • Femoral nerve block spread [Срок оценки: Immediate postoperative period]
  • Saphenous nerve block spread [Срок оценки: Immediate postoperative period]
  • Imaging time [Срок оценки: During FAB block procedure]
  • Needling time [Срок оценки: During FAB block procedure]
  • Total block performance time [Срок оценки: During FAB block procedure]

Критерии участия

Критерии включения

  • Age >18 years
  • Physical status ASA I-III
  • Fluent in Greek or English
  • Scheduled surgery: below-knee fractures
  • Tourniquet duration ≥45 minutes

Критерии исключения

  • Refusal to participate
  • Local inflammation at block site
  • Known allergy to study drugs
  • Morbid obesity (BMI >40)
  • Communication inability
  • Systemic neurological disease affecting peripheral nerves
  • Chronic pain therapy
  • Diabetic neuropathy
  • Uncontrolled hypertension

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Греция · 1 центр
  • University General Hospital Attikon — Athens

Идентификаторы

NCT: NCT07548567 · 802/30-12-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗