Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block

Официальное название

Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery

Обзор

This study compares two nerve block techniques-Rhomboid Intercostal with Sub-Serratus Plane Block versus Erector Spinae Plane Block-for pain relief after breast cancer surgery. It aims to determine which method provides better postoperative pain control, reduces opioid use, and improves recovery in patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University.

Подробное описание

This randomized controlled trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block with Sub-Serratus Plane Block (RIB + SSP) and Erector Spinae Plane Block (ESB)-in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer. Eighty female patients aged 18-65 years with ASA physical status II or III will be enrolled and randomly assigned to receive either RIB + SSP or ESB prior to surgery. Both blocks will be performed under ultrasound guidance 30-45 minutes before induction of general anesthesia.

The primary outcomes are postoperative pain scores measured using the Visual Analog Scale (VAS) and total opioid consumption in the first 24 hours after surgery. Secondary outcomes include intraoperative and postoperative hemodynamic parameters, time to first analgesic request, total intraoperative opioid use, recovery time, patient satisfaction, and incidence of adverse effects such as nausea and vomiting.

The study will be conducted at the National Cancer Institute - Cairo University from June 2025 to June 2026. Ethical approval will be obtained, and written informed consent will be collected. This study aims to identify the more effective and safer regional technique to improve postoperative recovery and reduce opioid dependence in breast cancer patients.

Вмешательства

• Процедура Rhomboid Intercostal Block with Sub-Serratus Plane Block
  Ultrasound-guided regional anesthesia combining two injections: Rhomboid Intercostal Block (20 mL of 0.25% bupivacaine injected between rhomboid major and intercostal space) Sub-Serratus Plane Block (20 mL of 0.25% bupivacaine injected between serratus anterior and ribs). Both performed 30-45 minutes before Modified Radical Mastectomy under general anesthesia.
• Процедура Erector Spinae Plane Block
  Ultrasound-guided regional block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, between the erector spinae muscle and the transverse processes. Performed 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy.

Первичные конечные точки

• Postoperative Pain Scores [Срок оценки: First 24 hours postoperatively]
• Total Opioid Consumption [Срок оценки: First 24 hours postoperatively]

Критерии участия

Критерии включения

• Female breast cancer patients undergoing Modified Radical Mastectomy (MRM)

ASA physical status II or III

Age between 18 and 65 years

Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²

Критерии исключения

• Patient refusal

ASA physical status IV

Age <18 years or >65 years

BMI < 20 kg/m² or > 35 kg/m²

Known allergy or contraindication to local anesthetics or opioids

History of psychological disorders or chronic pain

Contraindications to regional anesthesia (e.g., coagulopathy, local infection, peripheral neuropathy)

Severe respiratory, cardiac, hepatic, or renal disease

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

Египет · 1 центр

• National Cancer Institute - Cairo University — Cairo

Идентификаторы

NCT: NCT07041762 · NCI-CAIRO-RISS-ESPB-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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