Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
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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: transcutaneous electrical acupoint stimulation, sham transcutaneous electrical acupoint stimulation.
- Кому может быть актуально
- Состояния в реестре: Liver Cancer. Базовые параметры: 18 лет — 80 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
- Китай
- 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
Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial
Обзор
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy
Подробное описание
Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
Вмешательства
- Устройство transcutaneous electrical acupoint stimulation
transcutaneous electrical acupoint stimulation Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30min before anesthesia until be discharged from the postanaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted - Устройство sham transcutaneous electrical acupoint stimulation
Patients in the sham group will receive electrode attachment but without stimulation.
Первичные конечные точки
- The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery [Срок оценки: Up to 24 hours postoperatively]
Вторичные конечные точки (12)
- The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery [Срок оценки: Up to 72 hours postoperatively]
- The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery [Срок оценки: Up to 72 hours postoperatively]
- Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours [Срок оценки: Up to 72 hours postoperatively]
- Pain scores of pain at rest at 24, 48 and 72 hours postoperatively [Срок оценки: Up to 72 hours postoperatively]
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively [Срок оценки: Up to 72 hours postoperatively]
- The incidence of postoperative nausea and vomiting during the first 24,48,72 hours [Срок оценки: Up to 72 hours postoperatively]
- The incidence of a composite of postoperative pulmonary complications during hospitalization [Срок оценки: immediately after the end of surgery, and at the first 24 hours after surgery]
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery [Срок оценки: Up to 72 hours postoperatively]
- Time of Bowel function recovery [Срок оценки: Up to 72 hours postoperatively]
- Length of hospital stay [Срок оценки: From admittance to discharge]
- The postoperative sleep quality score [Срок оценки: Up to 72 hours postoperatively]
- The anxiety and depression scores [Срок оценки: Up to 72 hours postoperatively]
Критерии участия
Критерии включения
Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
Критерии исключения
Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs;
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
Китай · 1 центр
- West China Hospital — Чэнду
Идентификаторы
NCT: NCT06341270 · 2024HX1564