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Идёт набор NCT07553611

The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores

— Наблюдательное Regional Anaesthesia Arthroscopic Shoulder Surgery Hemidiaphragmatic Paralysis Recovery Quality

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: İnterscalene block group, Erector spinae plane block group, Costoclavicular block group, Supraclavivular block group.
Кому может быть актуально
Состояния в реестре: Regional Anaesthesia, Arthroscopic Shoulder Surgery, Hemidiaphragmatic Paralysis, Recovery Quality. 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
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Официальное название

Comparion of the Effects of Ultrasound-guided Interscalene Block, Erector Spinae Plane Block, Costoclavicular Block, and Supraclavicular Block on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery: a Prospective Observational Trial

Обзор

This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

Подробное описание

Arthroscopic shoulder surgery is a significant approach to diagnosing and treating rotator cuff tears, impingement syndrome, instability, SLAP and Bankart injuries, and other shoulder disorders. Applications of this technique have become increasingly popular in recent yeras. Howeveri although arthroscopic sholuder surgery is conderered minimally invasive, it has been reported to cause moderate to severe postoperative pain, which can hinder patient recovery and rehabilitation, and potentially even extend the hospital stay. Therefore, providing an effective postoperative analgesia strategy in these patients is critical for patient comfort, mobilization, and overall recovery. Various methods are employed to managepostoperative pain in patients undergoing arthroscopic shoulder surgery, with regional techniques being the most prevalent. These regional techniques provide both intraoperative and postoperative analgesia in shoulder surgeries. The aim of this study is to evaluate the effects of ultrasound-guided four block techniques on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

Вмешательства

  • Другое İnterscalene block group
    Before the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring
  • Другое Erector spinae plane block group
    Before the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring
  • Другое Costoclavicular block group
    Before the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring
  • Другое Supraclavivular block group
    Before the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring

Первичные конечные точки

  • Hemidiaphragmatic paralysis [Срок оценки: 30 minutes]
Вторичные конечные точки (3)
  • Recovery quality [Срок оценки: 5 minutes]
  • Postoperative analgesic consumption [Срок оценки: 24 hours]
  • Postoperative pain intensity [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • aged 18-65 years
  • American Society of Anaesthesiology (ASA) score I-III
  • body mass index (BMI) <30kg/m2
  • scheduled for elective arthroscopic surgery

Критерии исключения

  • ASA score ≥4
  • BMI ≥30 kg/m2
  • declining to give written informed consent
  • controendications for block application
  • history of mental or neurological disease, severe liver and/or kidney disease
  • history of moderate or severe pulmonary disease
  • abnormal preoperative chest X-ray findings
  • scheduled for emergency surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • University of Health Sciences, Antalya Training and Research Hospital — Antalya

Публикации

  • Shagufta N, Nishant S, Rajnish K, Adil A. Hemidiaphragmatic paralysis following costoclavicular versus supraclavicular brachial plexus block: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2025 Oct-Dec;41(4):587-599. doi: 10.4103/joacp.joacp_415_24. Epub 2025 Jul 9. PMID 41181256
  • Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841. PMID 31283740

Идентификаторы

NCT: NCT07553611 · 4/21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗