Меню
Идёт набор NCT07398352

Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation In Shoulder Surgery

Без фазы С лечением Interscalene Block Superficial Cervical Block Cerebral Perfusion Shoulder Surgeries

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: Interscalene brachial plexus block, Interscalene brachial plexus block and superficial cervical plexus block.
Кому может быть актуально
Состояния в реестре: Interscalene Block, Superficial Cervical Block, Cerebral Perfusion, Shoulder Surgeries. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison Of The Effect Of Interscalene Block Alone And The Combination Of Interscalene Block And Superficial Cervical Block On Brain Oxygenation And Carotid Artery Diameter In Shoulder Surgery

Обзор

The aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing shoulder surgery.

Подробное описание

This study aimed to compare the effects of interscalene block alone and interscalene block combined with superficial cervical plexus block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, and postoperative pain in patients undergoing shoulder surgery.

Peripheral nerve blocks, particularly interscalene block, are commonly used in shoulder surgery due to their superior analgesic efficacy. Cerebral oxygenation was assessed using near-infrared spectroscopy (NIRS), a non-invasive method that reflects regional tissue oxygenation. The effects of both block techniques on bilateral cerebral oxygenation and carotid artery diameter were evaluated using NIRS and ultrasonography, respectively

Вмешательства

  • Процедура Interscalene brachial plexus block
    After sedating the patient with 2 mg midazolam, baseline values will be obtained, and an interscalene block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute(min), T3: 10 min, T4: 15 min, and T5: 20 min. To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a sup
  • Процедура Interscalene brachial plexus block and superficial cervical plexus block
    After sedating the patient with 2 mg midazolam, baseline values will be obtained, and a combined interscalene and superficial cervical block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter(mm) (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute, T3: 10 minute, T4: 15 minute, and T5: 20 minute. To assess the quality of the block, the sensory block will be evaluated at 20 min

Первичные конечные точки

  • The effect of regional anesthesia on cerebral oxygenation [Срок оценки: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute]
Вторичные конечные точки (2)
  • The effect of regional anesthesia on carotid artery diameter [Срок оценки: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute]
  • The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumption [Срок оценки: From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively]

Критерии участия

Критерии включения

  • 18-65 years patient
  • American Society of Anesthesiologists (ASA) I-II patient

Критерии исключения

  • Age < 18 years or > 65 years
  • History of carotid endarterectomy
  • History of cerebrovascular accident(CVA)
  • Body Mass index (BMI)>35 kg/m²
  • Inability to cooperate or comply with study procedures
  • Liver and kidney failure
  • Pregnancy and breastfeeding
  • ASA pyhsical status III-V
  • Contraindication to regional anesthesia

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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sanliurfa Mehmet Akif Inan Education and Research Hospital — Sanliurfa

Публикации

  • Ahmadzadeh S, Naccari BP, Amedio LS, Koruna AE, Bass D, Shekoohi S, Kaye AD. Efficacy of Suprascapular Versus Interscalene Block for Post-Operative Pain Management in Shoulder Surgeries: A Narrative Review. Curr Pain Headache Rep. 2025 Dec 29;30(1):13. doi: 10.1007/s11916-025-01443-7. PMID 41457137
  • Cosarcan SK, Gurkan Y, Dogan AT, Koyuncu O, Ercelen O. Could Interscalene Block Possibly be Protective Against Cerebral Ischemia During Shoulder Surgery in a Beach Chair Position? Cureus. 2021 Jul 31;13(7):e16773. doi: 10.7759/cureus.16773. eCollection 2021 Jul. PMID 34476141
  • Kaye AD, Upshaw WC, Holley C, Bailey PD, Tassin JP, Frolov MV, Sudini S, Miller BC, Palowsky ZR, Kataria S, Ahmadzadeh S, Shekoohi S, Robinson CL. Overview and Comparison of Interscalene Block Techniques for Brachial Plexus Pain Management. Curr Pain Headache Rep. 2024 Dec 30;29(1):1. doi: 10.1007/s11916-024-01346-z. PMID 39739068

Идентификаторы

NCT: NCT07398352 · ISBSPBBO25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗