Идёт набор NCT03984656

Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.

Фаза III С лечением Analgesia Lidocaine Intensive Care Unit

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: lidocaine treatment, serratus plane block treatment.
Кому может быть актуально: Состояния в реестре: Analgesia, Lidocaine, Intensive Care Unit. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. Pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (ICU). A new type of locoregional anesthesia called Serratus plane block described by Blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. Serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. No studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. This technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. The investigators would like to conduct a preliminary study of superiority in the CHU Amiens intensive care unit, to study the interest of the Serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.

Вмешательства

Препарат lidocaine treatment
The index marks the upper edge of the lower rib of the selected intercostal space to avoid the vasculonervous bundle sitting at the lower part of the overlying rib.Non-targeted subcutaneous infiltration is performed in the drainage area with 5 to 10 mL of Lidocaine 20 mg / mL non-adrenaline, plane by plane, with regular aspiration until air or fluid confirming effusion.
Препарат serratus plane block treatment
The Serratus plane block is located at the level of the 5th rib, on the midaxillary line, on the drainage side, ultrasound guided. The block is performed with a 70 mm needle in the ultrasound plane, and the needle is directed postero-inferior, after visualization of the structures from the surface to the depth: dorsal muscle * anterior serratus large muscle (serratus anterior) * intercostal muscle * 4th and 5th ribs * pleura A single injection of 30 mL of Ropivacaine 4.75 mg / mL is performed a

Первичные конечные точки

Acute pain intensity measure [Срок оценки: at the start of inclusion (H0)]

Вторичные конечные точки (8)

measure of acute pain intensity at rest [Срок оценки: at the start of inclusion (H0)]
measure of acute pain intensity at expiration at the end of pleural drainage [Срок оценки: at the start of inclusion (H0)]
Change from baseline (HO) of acute pain at rest following drainage [Срок оценки: at one hour after patient inclusion]
Change from baseline (HO) of acute pain at rest following drainage [Срок оценки: at 6 hours after patient inclusion]
Change from baseline (HO) of acute pain at rest following drainage [Срок оценки: at 24 hours after patient inclusion]
Change from baseline (HO) of acute pain at expiration following drainage [Срок оценки: at 1 hour after patient inclusion]
Change from baseline (HO) of acute pain at expiration following drainage [Срок оценки: at 6 hours after patient inclusion]
Change from baseline (HO) of acute pain at expiration following drainage [Срок оценки: at 24 hours after patient inclusion]

Критерии участия

Критерии включения

patients over 18 years old.
non-intubated patient with spontaneous ventilation
free and informed consent of the patient,
affiliated to a social security scheme
hospitalized in ICU unit including surgical ICU, cardiothoracic and respiratory ICU or cardiothoracic and respiratory continuous care unit.
requiring pleural drainage gas or fluid
conscious patient, not sedated.