Меню
Набор скоро начнётся NCT07671352

Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery

Фаза IV С лечением Hemidiaphragmatic Paralysis Postoperative Pain Shoulder Surgery 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 interscalene brachial plexus block, Ultrasound-guided suprascapular nerve block, Ultrasound-guided costoclavicular brachial plexus block.
Кому может быть актуально
Состояния в реестре: Hemidiaphragmatic Paralysis, Postoperative Pain, Shoulder Surgery, Brachial Plexus Block. Базовые параметры: 18 лет — 80 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 →

Обзор

Shoulder surgery causes significant postoperative pain, and ultrasound-guided regional anesthesia is central to its management. The interscalene block (ISB) is the gold standard but frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis, limiting its use in patients with reduced pulmonary reserve. The suprascapular (SSNB) and costoclavicular (CCB) blocks are proposed diaphragm-sparing alternatives, but data directly comparing all three are limited. This randomised, double-blinded trial will compare the incidence of hemi-diaphragmatic paresis among ultrasound-guided ISB, SSNB, and CCB in elective shoulder surgery. Seventy-five ASA I-II patients aged 18-70 will be allocated 1:1:1 to one block. The primary outcome is the incidence of hemi-diaphragmatic paresis, measured by ultrasound diaphragmatic excursion before induction and after recovery in the PACU. Secondary outcomes include postoperative pain, analgesic consumption, and patient satisfaction. The investigators hypothesise that SSNB and CCB will cause less hemidiaphragmatic paresis than ISB while providing comparable analgesia.

Подробное описание

This randomized, double-blinded, parallel-group trial compares the effect of three ultrasound-guided regional anesthesia techniques on diaphragmatic function in elective shoulder surgery. The interscalene block (ISB), the gold standard, frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis. The suprascapular (SSNB) and costoclavicular (CCB) blocks preserve analgesia while sparing the phrenic nerve, but direct comparative data among all three are limited.

Seventy-five ASA I-II patients aged 18-70 scheduled for elective shoulder surgery will be randomized 1:1:1 (25 per group) using computer-generated allocation with sealed opaque envelopes. ISB: 10 mL 0.25% bupivacaine with dexmedetomidine 0.5 µg/kg; SSNB: 10 mL of the same mixture; CCB: 20 mL of the same mixture. All blocks are ultrasound-guided and performed before a standardised general anaesthetic.

Diaphragmatic excursion is measured by M-mode ultrasound of both hemidiaphragms at baseline (pre-induction), 30 minutes after the block, and in the PACU at a train-of-four ratio ≥0.9. Hemi-diaphragmatic paresis is graded as Complete (\>75% reduction or paradoxical movement), Partial (25-75%), or Normal (0-25%). The primary outcome is its incidence. Secondary outcomes include VAS pain at rest and movement (1, 3, 6, 12, 24 h), analgesic consumption, time to first rescue analgesia, block performance time, complications, and patient satisfaction.

Вмешательства

  • Процедура Ultrasound-guided interscalene brachial plexus block
    Ultrasound-guided interscalene brachial plexus block performed \~1 hour before surgery. With the patient supine and head rotated contralaterally, a high-frequency linear transducer identifies the C5-C6 roots between the anterior and middle scalene muscles. Using an in-plane technique, 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected with frequent aspiration.
  • Процедура Ultrasound-guided suprascapular nerve block
    Ultrasound-guided suprascapular nerve block performed \~1 hour before surgery. A linear high-frequency probe in the supraclavicular region identifies the suprascapular nerve. A 22-gauge echogenic needle is advanced in-plane to the nerve proximal to the transverse scapular ligament, and 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected under real-time ultrasound, confirming circumferential spread.
  • Процедура Ultrasound-guided costoclavicular brachial plexus block
    Ultrasound-guided costoclavicular brachial plexus block performed \~1 hour before surgery. With the operative arm abducted \~60°, a linear probe inferior to the mid-clavicle visualizes the three brachial plexus cords lateral to the axillary artery. An echogenic needle is advanced in-plane into the interfascial plane, and 20 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected with aspiration and ultrasound confirmation of homogeneous spread.

Первичные конечные точки

  • Incidence of hemi-diaphragmatic paresis [Срок оценки: From pre-induction baseline to PACU assessment at train-of-four ratio ≥0.9 (up to approximately 24 hours after the block]
Вторичные конечные точки (2)
  • Postoperative pain score at rest (static VAS) [Срок оценки: At 1, 3, 6, 12, and 24 hours postoperatively]
  • Patient satisfaction [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

Adults of both sexes, aged 18 to 70 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective shoulder surgery

Критерии исключения

Pulmonary disease or baseline diaphragmatic dysfunction Refusal to provide informed consent Pre-existing neuropathy in the operated limb Allergy to local anesthetics Infection at the injection site Coagulopathy Pregnancy

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

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Renard Y, Grape S, Gonvers E, Rossel JB, Goetti P, Albrecht E. Respiratory impact of local anaesthetic volume after interscalene brachial plexus block with extrafascial injection: a randomised controlled double-blinded trial. Br J Anaesth. 2025 Apr;134(4):1153-1160. doi: 10.1016/j.bja.2024.12.010. Epub 2025 Jan 23. PMID 39855930
  • Lee Y, Bang S, Chung J, Chae MS, Shin J. Costoclavicular block as a diaphragm-sparing nerve block for shoulder surgery: a randomized controlled trial. Korean J Anesthesiol. 2025 Feb;78(1):30-38. doi: 10.4097/kja.24595. Epub 2024 Dec 10. PMID 39654085

Идентификаторы

NCT: NCT07671352 · ANESTH50 · ANESTH50

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗