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Набор скоро начнётся NCT06742177

Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA)

Без фазы С лечением Opioid Consumption Numerical Rating Scale Demographic Data

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: Group Bi-level ESPB, Group M-TAPA block.
Кому может быть актуально
Состояния в реестре: Opioid Consumption, Numerical Rating Scale, Demographic Data. Базовые параметры: 18 лет — 110 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 →
Официальное название

Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA) in Laparoscopic Abdominal Surgery

Обзор

Laparoscopy is a surgical technique used for basic diagnosis and treatment. The advantages of laparoscopic techniques compared to open surgery have been demonstrated by studies. With the developing medicine and technology, minimally invasive approaches have been targeted in interventional procedures. In laparoscopic surgeries, access to the abdomen is provided with the help of a trocar and a temporary pneumoperitoneum is created with gas insufflation. Despite all these developments, even when laparoscopic techniques are used, postoperative pain is the most disturbing issue for patients. Postoperative pain can seriously reduce the quality of life in patients and acute pain can even trigger chronic pain syndromes. Epidural analgesia, paravertebral, erector spinae plane, intercostal nerve, transverse abdominis plane, external oblique, modified thoracoabdominal plane, rectus sheath block are used for anesthesia and analgesia during laparoscopic abdominal surgeries (LAS). In recent years, regional nerve blocks, including erector spinae plane block (ESPB) and modified thoraco-abdominal plane block (M-TAPA), have been applied for the treatment of pain in patients undergoing LAS due to various causes. ESPB was first described by Forero et al. in 2016 and has been frequently used for the treatment of acute pain in the postoperative period following abdominal surgeries. ESPB can be applied at any level from cervical to sacral, covering dermatomes appropriate for the surgical area under USG guidance. Cadaver studies for the ESPB mechanism have shown that local anesthetic spreads ipsilaterally and contralaterally and that it has analgesic efficacy both on the side where it is applied and on the opposite side. This peripheral nerve block, which is usually applied at a single level, can also be applied at bi-level. Studies have also shown that when ESPB is applied at bi-level, analgesic efficacy increases due to local anesthetic spread. M-TAPA is a new peripheral nerve block technique defined by Tulgar et al. It has high analgesic efficacy in thoraco-abdominal surgery. It has been shown to be advantageous in upper umbilical surgeries by involving more dermatomes compared to the transverse abdominis plane block. Lateral and anterior branches of thoraco-abdominal nerves are blocked with M-TAPA. It provides analgesia in a wide area between T5 and T12 and can also be applied for LAS. In our clinic, Bi-level ESPB or M-TAPA is routinely applied to suitable patients after anesthesia induction, and intraoperative anesthesia is maintained with inhalation and intravenous anesthetic agents. Multimodal analgesia management has been adopted as postoperative analgesia management.

Вмешательства

  • Процедура Group Bi-level ESPB
    The block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae mu
  • Процедура Group M-TAPA block
    The procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the e

Первичные конечные точки

  • Intraoperative opioid consumption. [Срок оценки: Intraoperative period]
Вторичные конечные точки (1)
  • Pain Scores [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

1-Patients over 18 years of age

2.Those with ASA score I-II-III

3.Those with body mass index (BMI) between 18-40

4.Patients who underwent LAS in the operating room with Bi-level ESPB or M-TAPA

Критерии исключения

  • Those under 18 years of age
  • Those with ASA score IV and above
  • Those with advanced co-morbidities
  • Those with a history of bleeding diathesis
  • Patients with infection in the area where the block will be performed
  • Those with BMI below 18 and above 40
  • Patients who underwent surgery under emergency conditions

8- Patients with advanced liver and kidney failure

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06742177 · AEŞH-EK1-2024-0067

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗