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Набор скоро начнётся NCT07366853

Feasibility and Safety of Sciatic Nerve Paraneural Sheath Block Using a Mid-Femoral Lateral Approach

Без фазы С лечением Adverse Effect Feasibility Study Safety and Effectiveness

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 lateral mid-femoral sciatic nerve block, Ultrasound-guided popliteal sciatic nerve block.
Кому может быть актуально
Состояния в реестре: Adverse Effect, Feasibility Study, Safety and Effectiveness. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Safety of Intraneural Sciatic Nerve Block Via Lateral Mid-femoral Approach: A Clinical Study

Обзор

This study is designed as a randomized controlled trial aiming to evaluate the feasibility and safety of ultrasound-guided mid-femoral lateral approach sciatic nerve paraneural sheath block, in order to provide a new sciatic nerve block approach for clinical practice that offers greater patient comfort and higher precision, thereby facilitating its use for specific patient populations and less experienced operators.

Подробное описание

In clinical practice, the popliteal approach to sciatic nerve paraneural sheath block is the most commonly used. Studies have found that compared with extraneural injection, ultrasound-guided sciatic nerve paraneural sheath block via the popliteal approach has a faster onset and provides longer postoperative sensory and motor blockade. Paraneural sheath block aims to achieve efficient, rapid, and precise nerve blockade using a low volume of local anesthetic. However, the popliteal approach requires knee flexion for performance, necessitating the patient to be in a prone or lateral decubitus position. For patients unable to flex the knee or those with positioning difficulties due to conditions such as lower limb fractures, this method is less applicable. For the above reasons, the popliteal sciatic nerve block has certain limitations.

The mid-femoral lateral approach demonstrates unique advantages: First, the patient can maintain a supine position throughout the procedure, significantly enhancing comfort and compliance. Second, the sciatic nerve is relatively superficial at this level, offering good ultrasonographic visualization and being distant from major blood vessels and nerves. This makes it applicable even in obese patients with thick subcutaneous fat and suboptimal ultrasound images, theoretically enhancing procedural safety. Therefore, it is considered an effective solution for patients with positioning restrictions, such as those with lower limb fractures and severe pain, holding high potential for clinical promotion and research significance.

Although the anatomical feasibility of this approach has been preliminarily confirmed, its practical feasibility and safety require validation through clinical studies. In particular, whether a successful "paraneural sheath block" can be consistently achieved at the mid-femoral lateral level, similar to the classic popliteal approach, remains to be explored. While some literature suggests its theoretical feasibility, there is a lack of prospective, systematic clinical research evidence to support its practical application feasibility (e.g., block efficacy, procedural difficulty, success rate) and safety (e.g., complication rates, incidence of nerve injury).

This study is designed as a randomized controlled trial aiming to evaluate the feasibility and safety of ultrasound-guided mid-femoral lateral approach sciatic nerve paraneural sheath block. The goal is to provide a new sciatic nerve block option for clinical practice that offers greater patient comfort and more precise blockade, facilitating its use for specific patient populations and less experienced operators.

Вмешательства

  • Процедура Ultrasound-guided lateral mid-femoral sciatic nerve block
    Ultrasound-guided sciatic nerve subparaneural sheath block via the lateral mid-femoral approach. Under combined ultrasound and nerve stimulator guidance, a single injection of 20 mL of 0.5% ropivacaine hydrochloride will be administered into the paraneural sheath at the mid-femoral level
  • Процедура Ultrasound-guided popliteal sciatic nerve block
    Ultrasound-guided sciatic nerve subparaneural sheath block via the conventional popliteal approach. Under combined ultrasound and nerve stimulator guidance, a single injection of 20 mL of 0.5% ropivacaine hydrochloride will be administered into the paraneural sheath at the popliteal fossa (prior to nerve bifurcation).

Первичные конечные точки

  • Rate of complete sensory blockade in the sciatic nerve distribution at 30 minutes after block completion [Срок оценки: At 30 minutes after completion of the local anesthetic injection.]
Вторичные конечные точки (12)
  • Block Success Rate [Срок оценки: At 30 minutes after block completion.]
  • Sensory Block Onset Time [Срок оценки: From the end of injection until complete sensory block is achieved (assessed every 30 seconds), up to 30 minutes.]
  • Duration of Sensory Block [Срок оценки: From block onset until first pain complaint, assessed up to 48 hours postoperatively.]
  • Motor Block Onset Time [Срок оценки: From the end of injection until complete motor block is achieved (assessed every 30 seconds), up to 30 minutes.]
  • Duration of Motor Block [Срок оценки: From block onset until full motor recovery, assessed up to 48 hours postoperatively.]
  • Time to First Request for Rescue Analgesia [Срок оценки: From end of surgery until first rescue request, assessed up to 24 hours postoperatively.]
  • Total Consumption of Rescue Analgesics within 24 Hours [Срок оценки: Within 24 hours after surgery.]
  • Postoperative Pain Intensity (NRS Scores) [Срок оценки: At 4, 8, and 24 hours after surgery.]
  • Incidence of Rebound Pain [Срок оценки: Within 48 hours after block resolution.]
  • Procedure-Related Times [Срок оценки: During the block procedure.]
  • Number of Needle Redirections [Срок оценки: During the block procedure.]
  • Incidence of Complications [Срок оценки: From block procedure up to 1 week postoperatively.]

Критерии участия

Критерии включения

  • Patients scheduled for elective unilateral surgery below the knee (e.g., internal fixation for ankle, metatarsal, or calcaneal fractures; hallux valgus correction; flatfoot reconstruction).
  • American Society of Anesthesiologists (ASA) physical status class I or II.
  • Aged 18 to 65 years.
  • Ability to understand the study procedure and provide written informed consent.

Критерии исключения

  • Contraindications to peripheral nerve block:
  • Known allergy or history of toxicity to local anesthetics.
  • Pre-existing neuropathy in the operative limb.
  • Severe coagulopathy.
  • Infection at the intended needle puncture site.
  • Systemic infection.
  • Requirement for simultaneous surgery at a site other than the unilateral lower limb below the knee.
  • Previous surgery or significant scarring in the area of the planned needle insertion for the sciatic nerve block.
  • Body mass index (BMI) > 35 kg/m².
  • Patients receiving chronic pain therapy or with a history of opioid abuse.
  • Inability to communicate or cooperate with the study assessments (e.g., due to cognitive impairment, language barrier, or psychiatric disorder).
  • Pregnancy or lactation.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • General Hospital of Ningxia Medical University — Иньчуань

Идентификаторы

NCT: NCT07366853 · Yan Ren-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗