Идёт набор NCT07659990

RISS Versus SPSIP Block in Modified Radical Mastectomy

Без фазы С лечением Postoperative Pain 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: Rhomboid Intercostal-Subserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block.
Кому может быть актуально: Состояния в реестре: Postoperative Pain, Breast Cancer. Базовые параметры: 18 лет — 75 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: 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 Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia and Dermatomal Spread After Modified Radical Mastectomy: A Randomized Double-Blind Trial

Обзор

This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.

Подробное описание

Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery.

The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited.

This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.

Вмешательства

Процедура Rhomboid Intercostal-Subserratus Plane Block
Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.
Процедура Serratus Posterior Superior Intercostal Plane Block
Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.

Первичные конечные точки

Total Postoperative Opioid Consumption [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (6)

Postoperative Pain Scores [Срок оценки: 0-24 hours after surgery]
Compartmental Pain Scores Using Numeric Rating Scale [Срок оценки: 0-24 hours after surgery]
Dermatomal Sensory Block Distribution [Срок оценки: 30 minutes after block performance]
Quality of Recovery-15 Score [Срок оценки: 24 hours after surgery]
Intraoperative Remifentanil Consumption [Срок оценки: During surgery]
Block- and Opioid-Related Complications [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

Female patients aged 18-75 years
ASA physical status I-III
Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia
Provision of written informed consent