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Идёт набор NCT06639503

Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

Фаза I С лечением Tibial Plateau Fractures

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: Bupivacain.
Кому может быть актуально
Состояния в реестре: Tibial Plateau Fractures. Базовые параметры: от 18 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial

Обзор

The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.

Подробное описание

The investigators are conducting this research study to find better ways of treating pain following knee surgery like the one the participant will be having. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control. This type of nerve block is commonly used to treat other knee pains, like that associated with arthritis, after knee replacements, and after repairs of the knee ligaments; however, it is considered experimental in your case, as its effects (good or bad) are unknown in the type of knee surgery the participant are undergoing.

The investigators plan is to decide at random, like the flip of a coin, whether to give numbing medication (0.25% bupivacaine) around the incision like the investigators normally would or give it instead to block the pain sensors around the knee. The participant would get medication either at the incision (shin) or the knee, depending on which arm the participant are in (research). The participant will also be given pain medication pills by your surgeon as part of the participant normal postoperative care (not research).

Вмешательства

  • Препарат Bupivacain
    5mL 0.25% bupivacain

Первичные конечные точки

  • Pain Ratings from Visual Analog Scale (VAS) [Срок оценки: one hour, two hours, and discharge from PACU]
Вторичные конечные точки (7)
  • Comparing blocks [Срок оценки: one hour after surgery, 2 hours after surgery, and discharge from PACU]
  • Block effect on range of motion [Срок оценки: PACU discharge]
  • VAS score daily first three days after surgery [Срок оценки: daily for three days after surgery]
  • Brief pain inventory (short scale) daily first three days after surgery [Срок оценки: daily first three days after surgery]
  • effect of genicular nerve blockade compared to standard peri-incisional local anesthetic [Срок оценки: 2 weeks post surgery]
  • Comparing blocks [Срок оценки: daily first three days after surgery]
  • Comparing blocks [Срок оценки: 2 weeks after surgery]

Критерии участия

Критерии включения

  • Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture

Критерии исключения

  • Subjects younger than 18
  • Polytraumatized Subjects
  • Subjects with pathologic fractures
  • Subjects with tibial plateau fractures treated nonoperatively
  • Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
  • Subjects with open fractures
  • Subjects with fracture-dislocations
  • Subjects with active or history of anxiety
  • Subjects with visual analog scale anxiety score ≥ 7 measured preoperatively
  • Subjects with chronic pain syndromes
  • Subjects with chronic opioid use
  • Subjects with illicit drug use disorder
  • Subjects with alcohol abuse disorder
  • Subjects with kidney disease precluding use of ketorolac
  • Subjects with liver disease precluding the use of acetaminophen
  • Subjects with allergy to acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opiates or local anesthesia
  • Subjects with inability to provide a visual analog scale score postoperatively
  • Subjects with contraindications to receiving peripheral nerve blocks, including relevant neurologic deficits, active infection at sites of injections - re-operation at the same site

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Chicago — Chicago

Идентификаторы

NCT: NCT06639503 · IRB23-0930

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗