Идёт набор NCT07650305

Bilevel Erector Spinae Plane Block Versus Pectoserratus Block for Analgesia in Modified Radical Mastectomy

Без фазы С лечением Breast Cancer

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: Ultrasound guided bilevel Erector spinae plane block (ESPB), Ultrasound guided Pectoserratus Block.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery

Обзор

Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Подробное описание

Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.

Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Вмешательства

Процедура Ultrasound guided bilevel Erector spinae plane block (ESPB)
Ultrasound guided bilevel Erector spinae plane block
Процедура Ultrasound guided Pectoserratus Block
ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block

Первичные конечные точки

Total post-operative morphine consumption. [Срок оценки: 24 hours after the surgery]

Вторичные конечные точки (5)

Total intra-operative fentanyl consumption [Срок оценки: 2-3 hours (Surgery time) surgery]
1st time opioids requested post-operative. [Срок оценки: 24 hours after the surgery]
Changes and stability in Mean Arterial Blood Pressure (MAP) [Срок оценки: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively]
Changes and stability in Heart Rate (HR) [Срок оценки: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively]
Pain scores using Visual analogue score [Срок оценки: 24 hours after the surgery]

Критерии участия

Критерии включения

Breast cancer female patients.
ASA class II and III.
Age ≥ 18 and ≤ 65 Years.
Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.