Ultrasound-Guided Mid-Point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block for Pain Management in Patients With Multiple Rib Fractures (A Prospective Randomized Double- Blinded, Non-inferiority Trial )
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: Mid point transverse to pleura block.
- Кому может быть актуально
- Состояния в реестре: Rib Fractures. Базовые параметры: 18 лет — 70 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures.
Подробное описание
Trauma is a major global health problem. In Egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. However.\[1\]Rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.\[2\] Multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. Which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. This is associated with increase in intensive care admissions and mortality (25%).\[3\] Hence, pain control is the cornerstone of rib fracture management. Modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including \[intrapleural, intercostal ,thoracic paravertebral nerve blockade (TPVB)\]. Despite the low rate of technical failure in TPVB execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.\[4\] Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications.
One of the most recently described technique is mid-point transverse process to pleura (MTP) block.\[2\] In MTP block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. With this technique, even if superior costotransverse ligament (SCTL) is not visible, effective block can be achieved. In addition, needle is placed far away from pleura minimizing the rate of pneumothorax.\[5\]
Вмешательства
- Процедура Mid point transverse to pleura block
TPVB and MTPB was performed at a spinal level midway between the uppermost and the lowest fractured rib, with the patient in a sitting position, and under complete aseptic conditions, a linear ultrasound probe (GE Healthcare-Logiq F6) will be placed oblique parasagittally 3 cm lateral to spinous process used to identify the transverse process, pleura, superior costotransverse ligament, and the paravertebral space at the target vertebral level. After skin and subcutaneous tissue infiltration wit
Первичные конечные точки
- The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block. [Срок оценки: 24hour]
Вторичные конечные точки (8)
- • NRS scores at different times up to 24 hours. [Срок оценки: 72hour]
- Time for first analgesic request. • Total 24 hours analgesic consumption. [Срок оценки: 24hour]
- • Total 24 hours analgesic consumption. [Срок оценки: 24hour]
- • Time for block performance. [Срок оценки: 30min]
- • Dermatomal block effect. [Срок оценки: 24hour]
- inspiratory volumes (mL) measured with a volume incentive spirometer. [Срок оценки: 72hour]
- respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation. [Срок оценки: 3 days]
- • Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality. [Срок оценки: 3days]
Критерии участия
Критерии включения
- Adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a CT chest scan).
Критерии исключения
- Significant head injury/unconsciousness (GCS less than 15).
- Patients with Pain score >6.
- those having significant trauma outside the chest wall, e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.
- Obese patients with body mass index ≥ 35.
- coagulopathy.
- History of drug allergy to local anesthetics.
- Patient refusal.
- Local infection at the injection site.
- Opioid addiction.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06981728 · fracture ribs