Идёт набор NCT07338916

Dose-Finding Study: MEV90 for Local Anesthetic in Interscalene Block for Supraclavicular Nerves Block

Без фазы С лечением Brachial Plexus Blockade Shoulder Surgery Superficial 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 Interscalene Block with Bupivacaine.
Кому может быть актуально: Состояния в реестре: Brachial Plexus Blockade, Shoulder Surgery, Superficial 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: Чили
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Minimum Effective Volume (MEV90) of Local Anesthetic Required for Ultrasound-Guided Interscalene Block for Supraclavicular Nerve Block: A Dose-Finding Study

Обзор

This study aims to determine the minimum effective volume (MEV90) of local anesthetic required to achieve sensory block of the supraclavicular nerves when performing a single-shot ultrasound-guided interscalene brachial plexus block (ISB). These nerves provide sensation to the skin over the clavicle and shoulder and are often involved in surgeries such as shoulder arthroscopy and clavicle repair.

Подробное описание

This prospective dose-finding study seeks to determine the minimum effective volume (MEV90) of local anesthetic required to achieve sensory block of the supraclavicular nerves following a single-shot ultrasound-guided interscalene brachial plexus block (ISB). These nerves, branches of the superficial cervical plexus, provide cutaneous innervation over the clavicle and shoulder and may contribute to postoperative pain after shoulder and clavicular surgery. Establishing MEV90 is clinically relevant to optimize analgesia while minimizing the risk of local anesthetic systemic toxicity.

The study employs a biased coin up-and-down sequential design, commonly used in regional anesthesia dose-finding trials. The initial volume is 12 mL of bupivacaine 0.5% with epinephrine (5 µg/mL), with subsequent volumes adjusted in 2 mL increments based on the prior patient's response. The maximum permitted volume is 30 mL.

All blocks are performed under ultrasound guidance by experienced anesthesiologists (≥60 ISBs), following standard safety protocols.

This intervention does not introduce additional risk beyond routine care, as ISB is the gold standard for shoulder surgery analgesia. Results will inform whether a single interscalene injection provides adequate coverage of supraclavicular nerves or if a separate cervical plexus block is necessary for procedures involving both plexuses, such as clavicle surgery. Findings may refine volume recommendations, improve analgesic strategies, and reduce unnecessary drug exposure.

Вмешательства

Препарат Ultrasound-Guided Interscalene Block with Bupivacaine
Participants will receive a single-shot interscalene brachial plexus block performed under real-time ultrasound guidance. The block targets the C5-C6 nerve roots between the anterior and middle scalene muscles using an in-plane technique. The local anesthetic is bupivacaine 0.5% with epinephrine (5 µg/mL). The injected volume ranges from 12 mL to 30 mL, determined by a dose-finding algorithm (biased coin up-and-down sequential design) to calculate the minimum effective volume (MEV90) for supracl

Первичные конечные точки

Minimum Effective Volume (MEV90) for Supraclavicular Nerve Block via Interscalene Approach [Срок оценки: 30 minutes after completion of the block]

Вторичные конечные точки (7)

Sensorimotor Block Score for Interscalene Block [Срок оценки: Every 5 minutes up to 30 minutes after block completion.]
Onset Time of Sensorimotor Block [Срок оценки: Up to 30 minutes after block completion.]
Sensory Block at Shoulder Arthroscopy Portals [Срок оценки: 30 minutes after block completion.]
Sensory Block of Auricular, Occipital, and Transverse Cervical Nerves [Срок оценки: 30 minutes after block completion.]
Pain Score During Block Procedure [Срок оценки: Immediately after block completion.]
Block Performance Times [Срок оценки: During block procedure.]
Incidence of Block-Related Adverse Events [Срок оценки: From block completion until end of surgery.]

Критерии участия

Критерии включения

Age ≥ 18 years
ASA physical status I to III
Body Mass Index (BMI) between 18 and 35 kg/m²
Weight ≥ 50 kg
Scheduled for shoulder arthroscopy requiring an interscalene brachial plexus block for analgesia
Able to provide informed consent