Modified External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block for Open Nephrectomy
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: Erector Spinae Plane Block, Modified External Oblique Intercostal Plane Block.
- Кому может быть актуально
- Состояния в реестре: Postoperative Pain, Open Nephrectomy. 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 →
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Официальное название
Comparison of Modified External Oblique Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Prospective Randomized Controlled Trial
Обзор
This prospective, randomized, assessor-blinded clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified External Oblique Intercostal Plane Block (EOIPB) in patients undergoing elective open nephrectomy under general anesthesia. Sixty adult patients will be randomized to receive either ESPB or EOIPB before surgical incision. All participants will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The study aims to determine whether one fascial plane block technique provides superior postoperative pain control and recovery following open nephrectomy.
Подробное описание
Open nephrectomy is associated with substantial postoperative pain that may impair recovery, delay mobilization, and increase opioid consumption. Regional anesthesia techniques have become important components of multimodal analgesia strategies aimed at improving postoperative outcomes while minimizing opioid-related adverse effects.
The erector spinae plane block (ESPB) and modified external oblique intercostal plane block (EOIPB) are ultrasound-guided fascial plane blocks that have demonstrated effectiveness in providing thoracoabdominal analgesia. However, evidence directly comparing these techniques in patients undergoing open nephrectomy remains limited.
This study is a prospective, randomized, controlled, assessor-blinded clinical trial conducted at a single tertiary academic center. Sixty patients aged 18 to 65 years with ASA physical status I-II who are scheduled for elective open nephrectomy will be enrolled and randomized in a 1:1 ratio to one of two study groups.
Participants assigned to the ESPB group will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Participants assigned to the EOIPB group will receive an ultrasound-guided modified external oblique intercostal plane block using the same volume and concentration of local anesthetic.
All patients will receive standardized general anesthesia, postoperative intravenous patient-controlled analgesia with tramadol, scheduled paracetamol, and rescue analgesics according to institutional protocols. Patients will be followed in the post-anesthesia care unit and at postoperative 2, 6, 12, and 24 hours.
The primary objective is to compare postoperative pain intensity between the two groups during the first 24 postoperative hours. Secondary objectives include comparison of opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, and perioperative hemodynamic parameters.
The results of this study may help identify the optimal regional analgesia technique for patients undergoing open nephrectomy and contribute to enhanced postoperative recovery.
Вмешательства
- Процедура Erector Spinae Plane Block
Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision. - Процедура Modified External Oblique Intercostal Plane Block
Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
Первичные конечные точки
- Pain intensity at rest [Срок оценки: 0, 2, 6, 12, and 24 hours after surgery]
Вторичные конечные точки (6)
- Pain intensity during movement [Срок оценки: 0, 2, 6, 12, and 24 hours after surgery]
- Total Opioid Consumption [Срок оценки: 24 hours after surgery]
- Rescue Analgesic Requirement [Срок оценки: 24 hours after surgery]
- Postoperative Nausea and Vomiting [Срок оценки: 24 hours after surgery]
- Heart Rate [Срок оценки: From induction of anesthesia until the end of surgery]
- Mean Arterial Pressure [Срок оценки: From induction of anesthesia until the end of surgery]
Критерии участия
Критерии включения
- Age between 18 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective open nephrectomy.
- Able and willing to provide written informed consent.
- Willing to comply with study procedures.
Критерии исключения
- Refusal to participate or inability to provide informed consent.
- Emergency surgery.
- Body mass index (BMI) greater than 35 kg/m².
- Known allergy or hypersensitivity to local anesthetics.
- Infection at the planned block insertion site.
- Coagulopathy or ongoing anticoagulant therapy.
- Pregnancy or breastfeeding.
- Prisoners or other vulnerable populations unable to provide independent consent.
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
Turkey (Türkiye) · 1 центр
- Tekirdağ Namık Kemal University — Tekirdağ
Идентификаторы
NCT: NCT07726550 · TNKU-EOIPB003