Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy

Официальное название

Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy: 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 pancreatectomy

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), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute stimulation session once daily on postoperative days 1, 2, and 3. 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
  Patients in the TEAS group, the acupoints are bilateral neiguan (PC6), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute stimulation session once daily on postoperative days 1, 2, and 3. 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
• Устройство sham transcutaneous electrical acupoint stimulation
  Patients in the sham group will receive electrode attachment but without stimulation.

Первичные конечные точки

• highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively. [Срок оценки: Up to 72 hours postoperatively]

Вторичные конечные точки (7)

• the highest NRS pain score at rest during 72 h 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: Up to 7 days postoperatively]
• Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery. [Срок оценки: Up to 3 days postoperatively]
• The postoperative sleep quality score [Срок оценки: Up to 3 days postoperatively]
• The plasma levels of C-reactive protein (CRP), procalcitonin (PCT), beta-endorphin, serotonin (5-HT), interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) on the 1st, 3rd, and 5th postoperative days [Срок оценки: Up to 5 days postoperatively]]

Критерии участия

Критерии включения

Age 18-80 years old; ASA physical status class I - III; Patients scheduled for pancreatectomy.

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; Have a history of Transcutaneous Electrical Acupuncture Stimulation (TEAS) or electroacupuncture treatment in the past or recently；

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.

Публикации

• Wu J, Chen J, Tang Q, Zhou L. Efficacy of perioperative transcutaneous electrical acupoint stimulation on postoperative pain and recovery in patients undergoing pancreatectomy: a study protocol for a randomized controlled trial. Trials. 2025 Dec 31;27(1):96. doi: 10.1186/s13063-025-09386-5. PMID 41469720

Идентификаторы

NCT: NCT06541561 · 2024HX0803

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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