- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07749040
Comparison Between Ultrasound Guided Quadratus Lumborum Block and Erector Spinae Plane Block as an Analgesic Modality in Renal Transplant Donors
Open surgery remains one of the approaches used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain (Gupta et al., 2013; Bravi et al., 2019).
Erector Spinae Plane block (ESPB) has grown as a standard analgesic approach for thoracic, abdominal, and extremities surgeries because of its speed, ease of execution, minimal risk of hypotension and safety for patients with coagulopathy. Although it is believed that the spinal neurons' ventral and dorsal rami are involved, the exact pathway is yet uncertain (Forero et al., 2016; Hamed et al., 2019).
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction (Capdevila et al., 2017).
Erector Spinae Plane block (ESPB), was initially described by Forero et al. (2016) for analgesia in thoracic neuropathic pain (Forero et al., 2016) and despite its recent literature it has also been widely used in both adults and children at deferent levels for deferent indications such as chronic shoulder pain (T2), thoracic surgery and breast surgery (T4-5) and upper abdominal surgery (T7-8) (Chin et al., 2017a; Chin et al., 2017b), however, most of the published trials regarding its analgesic effect following major open abdominal surgeries are case reports and rare. In this ultrasound-guided (USG) approach, a local anesthetic (LA) is injected between the erector spinae muscle and the trans-verse process of the thoracic vertebrae leading to spread of LA cephalad, caudally and through the paravertebral space (Forero et al., 2016; Chin et al., 2017a; Chin et al., 2017b).
Quadratus Lumborum block (QLB) is a widely used as regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery (Blanco et al., 2016; McCrum et al., 2018) it was defined for the first time by Blanco 2007 where the LA was injected at the anterolateral aspect of the QL muscle (type I QLB) (Blanco, 2007) Later, Børglum et al. (2013) used posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type III QLB) (Børglum et al., 2013).
Blanco and McDonnell, described another approach by injecting the LA at the posterior aspect of the QL muscle (type II QLB) (Blanco and McDonnell, 2013). Finally, the intramuscular QLB (type IV QLB) was performed by injecting LA directly into the QL muscle.
Hence, this study is designed to assess the efficacy of Quadratus lumborum block in comparison with erector spinae plane block in reducing post-operative pain and additional opioid requirement within the first 24 h in patients undergoing open nephrectomy under general anaesthesia.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Cairo, Египет
- AinShams university
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Inclusion criteria:
- Be over age 21
- Be willing to commit to the pre-donation evaluation process, surgery and the burden of recovery.
- No psychological condition.
- Fulfilling criteria for renal donation
Exclusion criteria
- Are under age 21
- Denying participating in the study
- Not fulfilling criteria for renal donation
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Quadratus lumborum nerve block
QLB will be done for patients in the study group at the end of surgery , before recovery of the patient from anesthesia.
All blocks will be performed by one anesthesiologist experienced in U/S block; the patient will be placed in the lateral decubitus position according to the selected site of surgical interven-tion.
The low-frequency convex probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., 124 S. E. ABD ELLATIF AND S. M. ABDELNABY Bothell, WA, USA) will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest after sterilization of the skin and draping, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body, With the psoas major muscle places anteriorly, the erector spinae muscle posteriorly
|
Two types of nerve will be applied to assess pain after renal transplantation in donors
|
|
Активный компаратор: Erector spinae nerve block
• In ESPB group In the ESPB group the patient will be placed in the lateral decubitus position according to the selected site of surgical intervention.
After sterilization and drapping of the skin of the upper back, counting down from seventh cervical vertebrae spine to identify the spine of the seventh thoracic vertebrae (T7).
This will be related to the tip of the scapular spine.
A high-frequency probe of Sonosite M Turbo ultrasonography (FUJIFILM sonosite, Inc., Bothell, WA, USA) will be placed across the T7 spine and the probe will be moved laterally to identify the trans-verse process of T7.
Thereafter, the probe will be moved to a sagittal plane to visualize the erector spinae muscles lying underneath the trapezius muscle.
A 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted medially inplane relative to the ultrasound probe and directed towards the transverse process.
Once the needle is underneath the anterior fascia of the erector spinae muscle, 1 ml
|
Two types of nerve will be applied to assess pain after renal transplantation in donors
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
Временное ограничение: 24 hours postoperative
|
24 hours postoperative
|
|
|
Time to first postoperative analgesia
Временное ограничение: 24 hours postoperatively
|
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
|
24 hours postoperatively
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively
Временное ограничение: 24 hours postoperative
|
24 hours postoperative
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MD118/2024
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .