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Идёт набор NCT05009771

Postoperative Pain Management of Caesarean Section

— Наблюдательное Postoperative Pain Caesarean Section Analgesia

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: Intravenous patient-control analgesia, Dinalbuphine sebacate.
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Caesarean Section, Analgesia. Базовые параметры: 20 лет — 40 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
Тайвань
Следующий шаг
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Официальное название

Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study

Обзор

Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.

Подробное описание

This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Вмешательства

  • Препарат Intravenous patient-control analgesia
    At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
  • Препарат Dinalbuphine sebacate
    Dinalbuphine sebacate is a prodrug of nalbuphine. With oil-based formulation, the active ingredient releases slowly and the effect lasts longer than nalbuphine. After delivery, a single 150 mg dose of dinalbuphine sebacate is administered intramuscularly.

Первичные конечные точки

  • Postpartum pain intensity [Срок оценки: Within 5 days after delivery]
Вторичные конечные точки (8)
  • Consumption of analgesics [Срок оценки: Within 5 days after delivery]
  • Incidence of complications [Срок оценки: Up to 5 days after delivery]
  • Ambulation [Срок оценки: Up to 5 days after delivery]
  • Breastfeeding [Срок оценки: Up to 5 days after delivery]
  • Gastrointestinal function recovery [Срок оценки: Up to 5 days after delivery]
  • Postnatal Depression assessment [Срок оценки: At baseline, 6 weeks and 3 months after delivery]
  • Satisfaction assessed by a four-point scale [Срок оценки: 6 weeks after delivery]
  • Chronic pain intensity [Срок оценки: 6 weeks and 3 months after delivery]

Критерии участия

Критерии включения

  • Aged 20 to 40.
  • Planing to undergo caesarean section with spinal anesthesia.
  • Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
  • American Society of Anesthesiology Physical Class 1-2.
  • Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.

Критерии исключения

  • Not willing to provide informed consent.
  • Unable to receive opioids or NSAIDs due to contraindication.
  • Long-term use of opioids or drug abuse.
  • Suffering from chronic pain disease.
  • Having medical history of mental illnesses.
  • Diagnosed with Pre-eclampsia or eclampsia.
  • Diagnosed with gestational diabetes.
  • Unsuitable for participation judged by investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 2 центра
  • MacKay Memorial Hospital Tamsui Branch — New Taipei City
  • MacKay Memorial Hospital — Taipei

Публикации

  • Hou PH, Chung SM, Huang JY, Hsu YW, Wong CS, Weng CS, Wang CH. Efficacy and safety of extended-release dinalbuphine sebacate in a multimodal analgesic regimen following cesarean section: A prospective observational study. Taiwan J Obstet Gynecol. 2026 May;65(3):538-545. doi: 10.1016/j.tjog.2026.02.003. PMID 42036188

Идентификаторы

NCT: NCT05009771 · 21MMHIS203e

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗