R.E.C.K vs Exparel in Robotic Nephrectomy
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 HCL, Exparel, Epinephrine, Clonidine HCL.
- Кому может быть актуально
- Состояния в реестре: Renal Carcinoma, Nephrectomy / Methods, Pain Management. 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
Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial
Обзор
The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
Подробное описание
Intra-op opioid administration will be collected and recorded for each participant via EMR review. While in the post anesthesia care unit and the remainder of the inpatient stay, the following will be assessed and captured: pain score via Numerical Rating Score (NRS) captured per standard of care, oral and IV opioid intake, and length of inpatient stay.
After discharge, the participants will be asked to record and timestamp the following in a provided take-home paper diary: pain via NRS in response to the prompt "How much pain are you experiencing right now?" and self-administered medications and dose (ibuprofen, acetaminophen, naproxen, and opioids) throughout the day.
Treatment will be administered intraoperatively.
Вмешательства
- Препарат Ropivacaine HCL
123 mg, intramuscular - Препарат Exparel
100 mL total dose - Intramuscular (IM), intraoperatively - Препарат Epinephrine
0.25 mg, intramuscular - Препарат Clonidine HCL
0.04 mg, intramuscular - Препарат Ketorolac
15 mg, intramuscular
Первичные конечные точки
- Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
Вторичные конечные точки (8)
- Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 7 Post-Surgery]
- Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K. [Срок оценки: Day of Surgery to Day 30 Post-Surgery]
Критерии участия
Критерии включения
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent.
- Planned robotic partial or radical nephrectomy
Критерии исключения
- Determined not to be a candidate to receive R.E.C.K or Exparel per the enrolling investigator
- Known pregnancy
- Chronic opioid use within 30 days (as per patient report) prior to randomization (defined as ≥ 30 MME/day)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator.
- Known allergy to R.E.C.K. and/or Exparel
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Levine Cancer — Charlotte
Идентификаторы
NCT: NCT07092566 · IRB00133736 · ONC-GU-2404