Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy

Официальное название

Analgesic Efficacy of External Oblique Intercostal Block Versus Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy

Обзор

To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.

Подробное описание

Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.

Regional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.

Although abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.

Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.

The external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern

Вмешательства

• Препарат Transversus abdominis plane block
  Patients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis m
• Препарат External Oblique Intercostal Plane Block
  Patients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique
• Препарат Control group
  Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia. General anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane.

Первичные конечные точки

• Degree of pain [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (6)

• Mean arterial pressure [Срок оценки: Till the end of surgery (up to 2hours)]
• Heart rate [Срок оценки: Till the end of surgery (up to 2hours)]
• Opioids consumption [Срок оценки: 24 hours after surgery]
• Morphine consumption [Срок оценки: 24 hours after surgery.]
• Time to rescue analgesia. [Срок оценки: 24 hours after surgery]
• Incidence of complications [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• Age (18-65) year.
• Both sexes.
• American Society of Anesthesiologists (ASA) class II and III.
• Cancer patients candidate for open nephrectomy .

Критерии исключения

• Patient refusal.
• Skin lesions or infection at the site of proposed needle insertion.
• Cognitive disorders.
• History of psychiatric disorders or drug abuse.
• Patients allergic to medication used.
• ASA class IV.
• Coagulopathy.
• Body mass index (BMI) more than 35.

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

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT06584695 · AP2407-201-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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