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Набор скоро начнётся NCT07394868

Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block

Наблюдательное Pain

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: Combined serratus plan block, Superficial serratus plane block.
Кому может быть актуально
Состояния в реестре: Pain. Базовые параметры: 18 лет — 80 лет · Женщины.
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 Analgesic Efficacy of Combined Superficial and Deep Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block Following Modified Radical Mastectomy Surgery

Обзор

Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks.

Подробное описание

Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks. Superficial serratus anterior plane block procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the serratus anterior muscle, under the latissimus dorsi muscle, and hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. KSAB procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the 4th rib, under the serratus anterior muscle, and onto the rib. Hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. The needle is then withdrawn 1-2 cm and positioned over the serratus anterior muscle, below the latissimus dorsi muscle. Hydrodissection with 2 ml of saline is performed to ensure accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. A total of 30 ml of bupivacaine will be injected, and the procedure will be terminated. In our clinic, multimodal analgesia is preferred for patients undergoing mastectomy. Peripheral nerve blocks (for all suitable and consenting patients) are used in conjunction with intravenous analgesic agents. Both block types are routinely applied in suitable patients who have undergone mastectomy.

Вмешательства

  • Другое Combined serratus plan block
    Combined serratus plan block
  • Другое Superficial serratus plane block
    Superficial serratus plane block

Первичные конечные точки

  • Opioid consumption [Срок оценки: 24 hours postoperative]
Вторичные конечные точки (6)
  • Numeric Rating Scale (NRS) [Срок оценки: 1 hour]
  • Numeric Rating Scale (NRS) [Срок оценки: 2 hour]
  • Numeric Rating Scale (NRS) [Срок оценки: 4 hour]
  • Numeric Rating Scale (NRS) [Срок оценки: 12 hour]
  • Numeric Rating Scale (NRS) [Срок оценки: 24 hour]
  • Patient satisfaction score [Срок оценки: 24 hour]

Критерии участия

Критерии включения

  • Individuals aged 18-80 years
  • Individuals with ASA scores I-II-III
  • Individuals with a Body Mass Index (BMI) between 18-40

Критерии исключения

  • Individuals under 18 years of age and over 80 years of age
  • Individuals with an ASA score of IV or higher
  • Individuals with advanced comorbidities
  • Individuals with a history of bleeding diathesis
  • Patients with infection in the area to be blocked
  • Individuals with a BMI below 18 and above 40

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
  • Ankara Etlik City Hospital — Ankara

Публикации

  • Chai B, Wang Q, Du J, Chen T, Qian Y, Zhu Z, Feng Z, Kang X. Research Progress on Serratus Anterior Plane Block in Breast Surgery: A Narrative Review. Pain Ther. 2023 Apr;12(2):323-337. doi: 10.1007/s40122-022-00456-z. Epub 2022 Dec 9. PMID 36484891
  • Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9. PMID 40721998
  • Ulger G, Zengin M, Kucuk O, Baldemir R, Kaybal O, Tunc M, Sazak H, Alagoz A. Comparison of combined deep and superficial serratus anterior block with thoracic paravertebral block for postoperative pain in patients undergoing video-assisted thoracoscopic surgery. Turk J Med Sci. 2024 Aug 4;54(5):1021-1032. doi: 10.55730/1300-0144.5881. eCollection 2024. PMID 39473759

Идентификаторы

NCT: NCT07394868 · Etlik Kübra Tez

Первоисточники (государственные реестры)

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