Prevention of Rebound Pain After Axillary Block
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: Saline, Dexamathsone 4mg/ml associated with experimental arm.
- Кому может быть актуально
- Состояния в реестре: Pain, Postoperative Care. Базовые параметры: 18 лет — 75 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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Официальное название
The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery
Обзор
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
Подробное описание
After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.
An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.
Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.
All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.
Sedation with 2 mg midazolam intravenously before block was administered.
In the group Dexamethasone (D), patients received axillary plexus block with a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
In the group control (X), patients received a 30 mlof a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% containing 2 ml saline solution.
For the axillary plexus block, patients were placed in a supine positionwith the arm in 90° of abduction and the forearm in flexion.A high frequency linear probe was placed on the transverse axis, over the axillary fold.The axillary artery, vein, and nerves surrounding the artery were visualized after scanning distally and proximally. The block needle (50 mm, 22G) was inserted in-plane from anterior to posterior, parallel to the ultrasound probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.
Before the surgical incision, the effectiveness of the sensory blockade of the axillary plexus was evaluated by a cold test in the different territories.
Post-operatively, all patients were put on systematic paracetamol 1 g every 6 hours, without exceeding 4 grams per day.
when the postoperative pain score (NRS) was \>3/10, intravenous tramadol 100 mg was administered.
Вмешательства
- Другое Saline
2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% - Препарат Dexamathsone 4mg/ml associated with experimental arm
Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
Первичные конечные точки
- incidence of Rebound pain [Срок оценки: 1 hour postoperatively to 48 hours postoperatively]
Вторичные конечные точки (5)
- Pain score at rest [Срок оценки: hour 1, hour 48 postoperative]
- Pain score at movement [Срок оценки: hour 1, hour 48 postoperative]
- The analgesic consumption [Срок оценки: hour 1, hour 24 postoperatively]
- Duration of motor block [Срок оценки: hour 1 postoperatively, 12 hours after nerve block]
- Blood glucose level [Срок оценки: after nerve block, 24 hours after surgery]
Критерии участия
Критерии включения
- • Age between 18 and 75 years old.
- Patients are current for hand surgery under axillary plexus block.
- Patients classified ASA physical status I, II and III
Критерии исключения
- \- Contraindication to regional anesthesia.
- Patient's disapproval.
- Impaired cognition.
- Patients whose surgery must be done under general anesthesia (complex hand surgery or association of other)
- Allergy to paracetamol, dexamethasone or opioids
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07313553 · IMKO-CE-2023-004