Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption in Patients Undergoing Major Abdominal Surgery

Обзор

This study aims to design a prospective, double-blind, randomized controlled trial to compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on postoperative visceral pain in patients undergoing major abdominal surgery. Participants will be randomly assigned to receive either taVNS or sham stimulation. The total consumption of opioids and other analgesics within 24 hours post-surgery in the AICU will be recorded, along with follow-up assessments of pain scores and quality of recovery scores (Qor-15) at 24 hours postoperatively.

Вмешательства

• Устройство Transcutaneous auricular vagus nerve stimulation
  Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left auricle was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency of 20 Hz, and pulse width of 200 μs. Each treatment sessio
• Устройство Sham Transcutaneous auricular vagus nerve stimulation
  The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was turned on, it either did not output any current or only delivered a brief sub-threshold current to simulate the sensation of the device being activated, without producing continuous neural stimulation.

Первичные конечные точки

• Total consumption of opioids [Срок оценки: within 24 hours postoperatively.]

Вторичные конечные точки (4)

• sleep quality score [Срок оценки: Postoperative first-night]
• Quality of Recovery Score [Срок оценки: 24 Hours Post-Operatively]
• Adverse events associated with taVNS [Срок оценки: 24 Hours Postoperatively]
• The incidence of opioid-related complications [Срок оценки: within 24 hours post-surgery]

Критерии участия

Критерии включения

• Age between 18 and 85 years, regardless of gender
• ASA physical status classification I-III
• Scheduled for elective major abdominal surgery under general anesthesia, with postoperative admission to the AICU for monitoring
• Anticipated duration of stay in the AICU is approximately 24 hours

Критерии исключения

• History of vagus nerve-related diseases (such as vasovagal syncope);
• Severe arrhythmias or implanted electronic devices such as pacemakers;
• Skin lesions, infections, or deformities at the site of external ear stimulation;
• Long-term preoperative use of opioid medications or sedatives;
• Allergy to study-related medications;

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07260266 · 2025-LP-778

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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