Набор скоро начнётся NCT07670078

Comparıson of Analgesıc Effıcacy of Dıfferent Volumes of Serratus Posterior Superıor Intercostal Plane Block After Modıfıed Radıcal Mastectomy Surgery

Без фазы С лечением Modified Radical Mastectomy Post Operative Pain, Acute Facial Plane Blocks

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: Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine.
Кому может быть актуально: Состояния в реестре: Modified Radical Mastectomy, Post Operative Pain, Acute, Facial Plane Blocks. 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: 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

Comparıson of Analgesıc Effectıveness of Dıfferent Volumes of Serratus Posterıor Superıor Intercostal Plane Block In Patıents Undergoıng Modıfıed Radıcal Mastectomy Surgery

Обзор

The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.

Подробное описание

The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks.

The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.

Вмешательства

Процедура Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution).
Процедура Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution).
Процедура Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution).

Первичные конечные точки

Total tramadol consumption [Срок оценки: Postoperative 24 hours]

Вторичные конечные точки (2)

Dermatome Area [Срок оценки: 30th minute after the block]
Numeric Rating Scale (NRS) Scores [Срок оценки: Postoperative 24 hours]

Критерии участия

Критерии включения

The study included adult patients over 18 years of age who underwent modified radical mastectomy under general anesthesia and were classified in risk groups I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.