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Набор скоро начнётся NCT07212127

Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery

Без фазы С лечением Oocyte Retrieval for IVF Pain

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: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA).
Кому может быть актуально
Состояния в реестре: Oocyte Retrieval for IVF, Pain. Базовые параметры: 21 лет — 42 лет · Женщины.
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
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Официальное название

Analgesic Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery

Обзор

This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA) combined with tramadol hydrochloride for analgesia during transvaginal ultrasound-guided oocyte retrieval, by comparing the analgesic effects and the prevention of postoperative nausea and vomiting between the TENS-WAA combined with tramadol hydrochloride group (experimental group) and the sham TENS-WAA combined with tramadol hydrochloride group (control group). Participants were randomly assigned to the experimental or control group. The experimental group received percutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to the procedure, at a frequency of 2Hz with current intensity adjusted to the maximum tolerable level.Tramadol hydrochloride 100mg was administered intramuscularly 20 minutes before surgery. The control group received sham stimulation at the lowest intensity under identical conditions. The primary outcome measure was the Visual Analogue Scale (VAS). Secondary outcome measures included skin conductance response, postoperative nausea scale, and vomiting scale.

Вмешательства

  • Устройство Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)
    Based on the theory of wrist and ankle needles, transcutaneous electrical nerve stimulation is a kind of analgesic treatment device that combines wrist and ankle needles with transcutaneous electrical nerve stimulation, and can be worn on the human wrist and ankle. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture Theory uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle needle, which has the advantages of easy to wear, concentration o

Первичные конечные точки

  • Pain VAS score [Срок оценки: Within 3 minutes following oocyte retrieval]
Вторичные конечные точки (3)
  • Galvanic Skin Response [Срок оценки: during procedure]
  • Nausea Rating Scale [Срок оценки: 30 minutes after oocyte retrieval]
  • Vomiting Rating Scale [Срок оценки: 30 minutes after oocyte retrieval]

Критерии участия

Критерии включения

  • Females aged between 21 and 42 years.
  • Patients diagnosed with infertility requiring oocyte retrieval for in vitro fertilisation-embryo transfer.
  • Body Mass Index (BMI) 18.5 ≤ BMI ≤ 29.9 kg/m².
  • Regular menstrual cycles with ultrasound monitoring demonstrating dominant follicle development and ovulation during the natural cycle; good ovarian reserve: follicle-stimulating hormone (FSH) < 10 IU/L, antral follicle count (AFC) > 6, anti-Müllerian hormone (AMH) > 1.5 ng/ml.
  • Undergoing ovarian stimulation therapy using follicle-stimulating hormone (FSH) or gonadotropin protocols.
  • Electing tramadol hydrochloride injection for analgesia during oocyte retrieval.
  • Voluntary participation with signed written informed consent.

Критерии исключения

  • History of other chronic pain conditions, or prolonged use of opioid medications, history of anaesthetic drug addiction, or chronic alcohol abuse.
  • Severe pelvic adhesions.
  • Presence of pacemakers or other implanted medical electronic devices.
  • Concurrent use of high-frequency surgical equipment, artificial heart-lung machines, medical shortwave therapy, or microwave therapy devices.
  • Presence of scarring or skin lesions at electrode application sites.
  • Severe anxiety, depression, or other psychiatric conditions impairing accurate description of sensations, or any other disorders potentially affecting pain perception.
  • Conditions contraindicating or affecting oocyte retrieval, such as coagulation disorders, acute pelvic inflammation, vaginitis, trichomoniasis, endometriomas, ovarian cysts.
  • Individuals with laparoscopically and/or ultrasonographically confirmed endometriosis.
  • Patients with ovarian hyporesponsiveness following conventional ovarian stimulation medication.

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
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Naval Medical University — Шанхай

Идентификаторы

NCT: NCT07212127 · CHEC2025-347

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗