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Набор скоро начнётся NCT06983886

The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery

Фаза I / Фаза II С лечением Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery

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: Tranexamic Acid, Normal Saline Solution (NSS), Lidocaine (drug).
Кому может быть актуально
Состояния в реестре: Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial

Обзор

The effect of local infiltration of tranexamic acid in orthognathic surgery remains unclear. This study was conducted to evaluate the difference in postoperative blood loss, measured by surgical drain output, following orthognathic surgery. The investigation involved a within-subject comparison, where each side of the mandible received a different local anesthetic solution: one side was infiltrated with a mixture of lidocaine with adrenaline and tranexamic acid, while the other side received lidocaine with adrenaline and normal saline.

Вмешательства

  • Препарат Tranexamic Acid
    A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of tranexamic acid (50 mg/ml), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after completion of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before the surgical incision was mad
  • Препарат Normal Saline Solution (NSS)
    A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of normal saline (NSS), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after the induction of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before making the surgical incision.
  • Препарат Lidocaine (drug)
    A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of normal saline (NSS) or 5 ml of tranexamic acid (50 mg/ml) depends on allocated group, resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after the induction of general anesthesia, followed by a 5-minute waiting period to allow the a

Первичные конечные точки

  • Postoperative blood loss [Срок оценки: 24 hours and 48 hours after the end of intervention]
Вторичные конечные точки (9)
  • Postoperative pain score [Срок оценки: 24 hours and 48 hours after the end of intervention]
  • Postoperative edema [Срок оценки: At 48 hours and 1 week after the end of intervention]
  • Surgical filed visibility [Срок оценки: Intraoperatively]
  • Headaches (Adverse events of tranexamic acid) [Срок оценки: within one week after end of the intervention]
  • Nausea vomiting (Adverse events of tranexamic acid) [Срок оценки: within one week after end of the intervention]
  • Seizure (Adverse events of tranexamic acid) [Срок оценки: within one week after end of the intervention]
  • Thromboembolic events (Adverse events of tranexamic acid) [Срок оценки: within one week after end of the intervention]
  • Drug allergy (Adverse events of tranexamic acid) [Срок оценки: within one week after end of the intervention]
  • Local irritation [Срок оценки: within one week after end of the intervention]

Критерии участия

Критерии включения

  • Patients aged 18-50 years
  • undergoing orthognathic surgery (Bilateral sagittal split ramus osteotomies (BSSRO), with or without Le Fort I maxillary osteotomy)
  • ASA physical status I-II

Критерии исключения

  • Genioplasty in the operation
  • History of allergy to tranexamic acid
  • History of thromboembolic disorders
  • Use of medications affecting blood coagulation (antiplatelet or anticoagulants) within the past 2 weeks
  • History of cerebrovascular disease
  • Pregnant or breastfeeding women

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Bangkok

Идентификаторы

NCT: NCT06983886 · MURA2025/288

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗