Идёт набор NCT06384664

Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Без фазы С лечением Pain, Postoperative Intrathoracic Procedure

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: Atricure's crysoSPHERE probe, Standard of Care.
Кому может быть актуально: Состояния в реестре: Pain, Postoperative, Intrathoracic Procedure. 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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Обзор

The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.

Вмешательства

Устройство Atricure's crysoSPHERE probe
Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.
Процедура Standard of Care
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Первичные конечные точки

Severity of pain in the peri-operative period [Срок оценки: Post-op day 1 and day of hospital discharge, approximately 3 days]
Inflammatory cytokine levels as measured by blood samples [Срок оценки: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery]
Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score [Срок оценки: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery]
Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) [Срок оценки: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop]
Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) [Срок оценки: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop]

Вторичные конечные точки (3)

Quality of life score as measured by SF-36 Health questionnaire [Срок оценки: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.]
Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) [Срок оценки: Up to 180-days postop]
Workflow/time [Срок оценки: Up to 180-days postop]

Критерии участия

Критерии включения

Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
Patient is opioid naïve