Compare Analgesia Between MTP Block And ESPB in MRM
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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 Erector Spinae Plane block, Ultrasound guided Mid-point to Pleura block.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 60 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
- Египет
- 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
Comparative Study Between Ultrasound Guided Mid-point Transverse Process to Pleura Block And Erector Spinae Plane Block For Perioperative Analgesia In Modified Radical Mastectomy In Breast Cancer Patients
Обзор
This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries
Подробное описание
Patients participants will be randomized into 3 groups:
Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.
Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.
Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.
Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
Вмешательства
- Процедура Ultrasound guided Erector Spinae Plane block
Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaest - Процедура Ultrasound guided Mid-point to Pleura block
Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4t
Первичные конечные точки
- post-operative opioid (morphine) consumption in the 1st 24 hours [Срок оценки: 24 hours]
Вторичные конечные точки (7)
- Time to first rescue analgesia, starting after extubation. In minutes [Срок оценки: 24 hours]
- Total dose of fentanyl required intraoperative (including induction dose) in microgram [Срок оценки: 24 hours]
- Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain [Срок оценки: 24 hours]
- Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading. [Срок оценки: 24 hours]
- Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading. [Срок оценки: 24 hours]
- Heart rate (per minute) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively [Срок оценки: 24 hours]
- Mean arterial blood pressure (mmHg) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively [Срок оценки: 24 hours]
Критерии участия
Критерии включения
- ASA I-II.
- Undergoing modified radical mastectomy surgery.
- Body mass index (BMI) from 18.5 to 30 kg/m2
Критерии исключения
- Patient refusal.
- Known allergy to local anesthetics.
- Bleeding disorders; platelets count <50,000 , prothrombin concentration < 60% or any coagulopathy disorder.
- Use of any anti-coagulants.
- Inability to provide informed consent.
- ASA III-IV.
- Neurological disorders.
- Patient with psychiatric disorders
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Египет · 1 центр
- National cancer institute, Cairo University — Cairo
Идентификаторы
NCT: NCT06888258 · AP2407-201-014