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Идёт набор NCT07396545

External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastrectomy

Без фазы С лечением Postoperative 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: External Oblique Intercostal Plane Block, Erector Spinae Plane Block (ESPB) group.
Кому может быть актуально
Состояния в реестре: Postoperative Pain. Базовые параметры: от 18 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Ultrasound-guided External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastrectomy

Обзор

Postoperative pain is highly prevalent following laparoscopic radical gastrectomy. Although the erector spinae plane block (ESPB) can effectively alleviate this pain, it still has many limitations. The external oblique intercostal plane block (EOIB) is a novel nerve block technique that may provide well postoperative analgesia for upper abdominal surgery. Therefore, this study employs a non-inferiority randomized controlled trial design to verify that the analgesic effect of EOIB is not inferior to that of ESPB, thereby offering more options for regional analgesia strategies in laparoscopic radical gastrectomy.

Подробное описание

Laparoscopic radical gastrectomy (including subtotal and total gastrectomy) is the most commonly used surgical approach for gastric cancer. Although this technique is less invasive than traditional open surgery, more than 50% of patients still experience moderate to severe acute pain in the early postoperative period, making effective postoperative pain management essential. Regional nerve blockade techniques have become a key component of postoperative analgesia due to their reliable analgesic effect and significant reduction in opioid consumption.

The erector spinae plane block (ESPB) is considered a relatively safe nerve block for upper abdominal surgery analgesia. However, the spread of the local anesthetic and the resulting block effect are unpredictable. Moreover, ESPB cannot be performed with the patient in the supine position and may present technical challenges in obese patients.

The external oblique intercostal plane block (EOIB) is a recently proposed regional block technique for the upper abdomen. This block involves injecting local anesthetic into the superficial fascial plane between the external oblique muscle and the intercostal muscles, thereby blocking the anterior rami and cutaneous branches of the intercostal nerves from T6-T10, which can provide effective analgesia for upper abdominal incision areas.

Nevertheless, current research on the analgesic effect of EOIB after laparoscopic radical gastrectomy remains limited, particularly lacking high-quality, prospective, randomized controlled studies to verify whether EOIB can achieve analgesic effects comparable to those of ESPB. Therefore, this study adopts a non-inferiority randomized controlled trial design to verify that the postoperative analgesic effect of EOIB is not inferior to that of ESPB, providing more options for regional analgesia strategies in laparoscopic radical gastrectomy.

Вмешательства

  • Процедура External Oblique Intercostal Plane Block
    With the patient in the supine position, a high-frequency linear array probe (6-15 MHz) is used to perform a sagittal parasagittal oblique scan at the level of the 6th rib, between the right anterior axillary line and midclavicular line. The external oblique muscle, intercostal muscles, and ribs are identified. Using an in-plane technique, a 21G, 100mm block needle is inserted from a superomedial to inferolateral direction, with the needle tip positioned in the plane between the external oblique
  • Процедура Erector Spinae Plane Block (ESPB) group
    With the patient in the lateral decubitus position (surgical side up), a low-frequency convex array probe (2-5 MHz) is used to perform a sagittal scan approximately 2-3 cm lateral to the spinous process of T8 or T9. The transverse process and the erector spinae muscle are identified. Using an out-of-plane technique, a 21G, 100mm block needle is advanced until contact is made with the transverse process. The needle is then withdrawn 1-2 mm to position its tip within the fascial plane deep to the

Первичные конечные точки

  • Cumulative opioid consumption within 24 hours postoperatively [Срок оценки: 24 hours after surgery]
Вторичные конечные точки (3)
  • Pain Intensity [Срок оценки: 2, 6, 12, 24, 48, and 72 hours postoperatively]
  • Quality of Recovery [Срок оценки: 24,48,72 hours after surgery]
  • sleep quality [Срок оценки: 24,48,72 hours after surgery]

Критерии участия

Критерии включения

  • Patients aged over 18 years
  • Classified as ASA I-III
  • Scheduled for elective laparoscopic radical gastrectomy under general anesthesia
  • Voluntarily participated and provided written informed consent.

Критерии исключения

  • Chronic opioid dependence or prior use of analgesic medications for >3 months;
  • Inability to communicate due to severe dementia, language barriers, or terminal illness;
  • History of central and/or peripheral nervous system disorders;
  • Severe renal insufficiency (serum creatinine >442 μmol/L or requiring renal replacement therapy) or severe hepatic insufficiency (Child-Pugh class C);
  • Allergy to local anesthetics.
  • Expected to be transferred to ICU after surgery.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • General hospital of Ningxia medical university — Иньчуань

Идентификаторы

NCT: NCT07396545 · Lingzi-2026-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗