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Набор скоро начнётся NCT07688395

Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Analgesia After Shoulder Arthroscopy

Без фазы С лечением Shoulder Arthroscopic Surgery

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: cervical erector spinae plane block, Infraspinatus Teres Minor Interfascial Plane Block, Bupivacaine %0.25 (isobaric).
Кому может быть актуально
Состояния в реестре: Shoulder Arthroscopic Surgery. 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block

Обзор

The shoulder, being an anatomical region innervated by different nerves, has a wide variety of analgesic approaches, which differ depending on the practitioner. New approaches are being developed based on the different innervation channels demonstrated in clinical and cadaver studies. Over time, the effectiveness of axillary block, suprascapular block, interscalene block, local infiltration, and various combinations, as well as non-regional methods, has been observed. The goal of these approaches is to achieve the highest possible level of patient comfort, high analgesic efficacy, and minimal complications. Studies have shown that the interscalene block has the highest analgesic efficacy and the most ideal postoperative results; therefore, it is frequently used as the gold standard in this field. Providing effective analgesia with a single intervention can also be cited as an aspect that increases patient comfort and simplifies the procedure. In interscalene block; unilateral transient diaphragmatic paralysis due to the spread of local anesthetics to the C7 nerve root, respiratory problems and potential spinal/epidural complications, new approaches are being followed and researched. Results from cervical/high thoracic erector spinae plane block (ESPB) and infraspinatus-teres minor interfascial plane block (ITMIPB) studies, which are the subject of new studies, strengthen the hypothesis that they provide effective analgesia. Neither of these blocks, performed with ultrasonography, carries the risks present in interscalene block. Although the usual risks of a peripheral nerve block are present for these procedures; the block sites are considered safer due to its distance from vascular structures and the reduced risk of additional complications. While small sample studies exist for each type of block, no studies comparing their effectiveness have been found. Besides reduced complications, another advantage of these two blocks is their ability to provide effective analgesia with a single-point injection. The aim of this study is to compare the analgesic efficacy of Cervical Erector Spine Plane Block (ESP) and Infraspinatus-Teres Minor Interfascial Plane Block (ITMIPB) applied for postoperative analgesia in ASA I-III patients undergoing shoulder surgery.

Вмешательства

  • Процедура cervical erector spinae plane block
    Before shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia
  • Процедура Infraspinatus Teres Minor Interfascial Plane Block
    Before surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia
  • Препарат Bupivacaine %0.25 (isobaric)
    In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25.

Первичные конечные точки

  • Postoperative pain intensity [Срок оценки: Postoperative 1., 6., 12. and 24. hour]
Вторичные конечные точки (3)
  • Total postoperative analgesic consumption [Срок оценки: 24 hours after surgery]
  • Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: 24 hours after surgery]
  • Block-related complications [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

  • Adults scheduled for elective shoulder arthroscopy
  • ASA I-II-III patients
  • Patients age between 18-80

Критерии исключения

  • Patients with previously known allergy to local anesthetics.
  • Patients with insufficient pulmonary functions (Severe obstruction or restriction in Pulmonary Function Test)
  • Patients with ASA IV or higher
  • Patients who suffered from any complications related to anesthesia or surgery
  • Patients with additional body part injury
  • Pregnant or breastfeeding women

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
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Taksim Educational and Research Hospital — Istanbul

Публикации

  • Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652. PMID 28786899
  • Ma D, Wang R, Wen H, Li H, Jiang J. Cervical erector spinae plane block as a perioperative analgesia method for shoulder arthroscopy: a case series. J Anesth. 2021 Jun;35(3):446-450. doi: 10.1007/s00540-021-02907-x. Epub 2021 Mar 8. PMID 33686465
  • Ahiskalioglu A, Karapinar YE, Dagci Y, Yayik AM, Ciftci B, Tulgar S. An alternative sonographic approach to infraspinatus-teres minor interfascial plane block: make it easy. Minerva Anestesiol. 2025 Apr;91(4):359-361. doi: 10.23736/S0375-9393.24.18697-X. Epub 2025 Feb 6. No abstract available. PMID 39912574
  • Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511. PMID 28898151
  • Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5. PMID 35550031

Идентификаторы

NCT: NCT07688395 · 2024-KAEK-12

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗