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Идёт набор NCT07736989

Ultrasound-Guided Bilateral Transversalis Fascia Plane Block With vs Without Dexamethasone for Cesarean Delivery

— Наблюдательное Pain, Postoperative 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pain, Postoperative, Analgesia. Базовые параметры: 18 лет — 50 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Postoperative Analgesic Outcomes After Bilateral Ultrasound-Guided Transversalis Fascia Plane Block With or Without Dexamethasone in Cesarean Delivery: A Retrospective Cohort Study

Обзор

Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and effective postoperative pain management is essential to facilitate early mobilization, maternal-infant bonding, breastfeeding, and overall recovery. Ultrasound-guided transversalis fascia plane block (TFPB) has become an increasingly utilized component of multimodal analgesia following cesarean delivery because it provides effective somatic analgesia of the lower anterior abdominal wall. Adjuvants such as dexamethasone are frequently added to local anesthetics with the aim of prolonging block duration and improving postoperative analgesia; however, evidence regarding the clinical benefits of dexamethasone as an adjunct in TFPB remains limited. At our institution, bilateral ultrasound-guided TFPB is routinely performed for postoperative analgesia in patients undergoing cesarean delivery under spinal anesthesia, provided there is no contraindication and informed consent has been obtained. According to the treating anesthesiologist's routine clinical preference, dexamethasone may be added to the local anesthetic solution in some patients, whereas others receive local anesthetic alone. This retrospective cohort study will review the medical records and postoperative follow-up forms of patients who underwent cesarean delivery between November 1, 2025, and June 30, 2026. Postoperative analgesic outcomes, including opioid consumption, pain scores, time to first analgesic request, postoperative nausea and vomiting, recovery quality, and block-related adverse events, will be compared between patients receiving bilateral TFPB with dexamethasone and those receiving bilateral TFPB without dexamethasone. The findings are expected to provide real-world evidence regarding the potential contribution of dexamethasone to the analgesic efficacy of bilateral TFPB following cesarean delivery.

Первичные конечные точки

  • Cumulative opioid consumption during the first 24 postoperative hours [Срок оценки: First 24 hours after surgery]
Вторичные конечные точки (3)
  • Postoperative pain intensity [Срок оценки: 1, 3, 6, 9, 12, 18, and 24 hours after surgery]
  • Time to first analgesic request [Срок оценки: Within the first 24 postoperative hours]
  • Quality of postoperative recovery [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

  • Female patients aged 18-50 years.
  • Elective cesarean delivery performed under spinal anesthesia.
  • Bilateral ultrasound-guided transversalis fascia plane block performed for postoperative analgesia.
  • Availability of complete perioperative and postoperative follow-up records.

Критерии исключения

  • Emergency cesarean delivery.
  • General anesthesia or combined spinal-epidural anesthesia.
  • Contraindication to transversalis fascia plane block.
  • Chronic opioid use.
  • Allergy to bupivacaine or dexamethasone.
  • Missing or incomplete postoperative follow-up data.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bahcesehir Unişversity Medicalpark Goztepe hospital — Istanbul

Публикации

  • Cadirci DY, Aydin ME, Ahiskalioglu EO, Celik EC, Yayik AM, Coruh S, Senocak GNC, Ciftci B, Ahiskalioglu A. Intrathecal morphine versus transversalis fascia and transversus abdominis plane blocks combination on obstetric quality of recovery after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 17;26(1):46. doi: 10.1186/s12871-025-03559-0. PMID 41408168
  • Dost B, DE Cassai A, Bugada D, Balzani E, Karapinar YE, Beldagli M, Ozkal Yalin MS, Tulgar S, Ahiskalioglu A. The analgesic effect of transversalis fascia plane block after cesarean delivery: a systematic review and meta-analysis with trial sequential analysis. Minerva Anestesiol. 2025 Jun;91(6):564-572. doi: 10.23736/S0375-9393.25.18771-3. PMID 40693479

Идентификаторы

NCT: NCT07736989 · TFPBinCD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗