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Идёт набор NCT07174440

Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block

Без фазы С лечением 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: Ropivacaine (Epidural analgesia), Dexmedetomidine, Iohexol, QST Procedure.
Кому может быть актуально
Состояния в реестре: Pain. Базовые параметры: 21 лет — 75 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
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Официальное название

Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy

Обзор

As per usual care for spine surgery, participants will have their back cleaned with alcohol and a needle will be placed using ultrasound for the ESP block. Through the needle, a small catheter will be placed in the participants back and the needle removed. Approximately one hour prior to the start of surgery, a numbing medication (ropivacaine, similar to Novocaine) in combination with dexmedetomidine (a pain medicine that is used in nerve block and that is not a narcotic) and contrast dye (iohexol) will be injected through the catheter. Participants will then go through the QST procedure (test of buzzing sensation and temperature sensation through pads applied to their skin) to assess the numb areas and then head to the operating room. In the operating room, the catheter will be removed after the surgeon obtains baseline CT scan images of the spine. Once surgery is completed, investigators will record pain scores over the next four days in the hospital and the amount of pain medication needed for controlling pain related to the surgery.

Вмешательства

  • Препарат Ropivacaine (Epidural analgesia)
    The block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care
  • Препарат Dexmedetomidine
    The block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care
  • Препарат Iohexol
    The block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care except for iohexol which is used for study purposes.
  • Процедура QST Procedure
    The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.

Первичные конечные точки

  • Verbal pain score as measured by the numerical rating scale (NRS) [Срок оценки: 12 hours after surgery]
Вторичные конечные точки (5)
  • Patient-reported outcome to assess the quality of recovery as measured by the QoR-15 [Срок оценки: Daily during hospital stay, up to 4 days]
  • Time to oral food intake as measured by patient report [Срок оценки: Daily during hospital stay, up to 4 days]
  • Time to ambulation as measured by patient report [Срок оценки: Daily during hospital stay, up to 4 days.]
  • Length of hospital stay as measured by medical record review [Срок оценки: Up to 5 days]
  • Number of intraoperative events as measured by medical record review. [Срок оценки: Up to 12 hours after surgery]

Критерии участия

Критерии включения

  • Age range: Adult patients 21-75 years of age
  • ASA status: I-III
  • Planned lumbar spine fusion involving no more than three levels
  • Ability to ambulate prior to surgery

Критерии исключения

  • Previous lumbar spine surgery
  • Metastatic cancer with involvement of the lumbar spine
  • eGFR < 60 mL/min/1.73m2
  • Active liver disease (hepatitis or cirrhosis)
  • Confirmed allergy to ropivacaine, dexmedetomidine or iohexol
  • Cognitive impairment resulting in inability to rate pain scores
  • Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07174440 · STUDY20241500

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗