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Идёт набор NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Фаза III С лечением Opioid Consumption, Postoperative Multimodal Analgesia Robotic Assisted Laparoscopic Surgery Robotic Assisted Laparoscopic Radical Prostatectomy

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: multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription, pre-implementation baseline including opioid.
Кому может быть актуально
Состояния в реестре: Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy. Базовые параметры: от 45 лет · Мужчины.
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

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway

Обзор

This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.

Подробное описание

The Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) study will implement and systematically evaluate an opioid-free discharge pathway (OFP) after robotic-assisted laparoscopic prostatectomy (RALP) at Brigham and Women's Hospital and Brigham \& Women's Faulkner Hospital. Patients are counseled pre-operatively and offered participation. Data will be compared across three prospectively studied groups: pre-implementation historical baseline (current practice), post-implementation ROPES with multimodal analgesia pathway alone (which requires patients to call phone line after discharge to request opioid if pain uncontrolled), and post-implementation ROPES with multimodal analgesia pathway plus up-front small opioid prescription. Standardized multimodal analgesic therapy is provided to all participating patients following study implementation, with opioids used only as needed. There is no change to the surgery and anesthesia plan (though standard care at our center includes injection of local anesthetic to incisions and ketorolac is encouraged at end of the procedure), and patients are allowed opioids while admitted to the post-op recovery area. The study aims to reduce postoperative opioid use while maintaining safety and quality outcomes; this will assess non-inferiority of ROPES OFP in comparison to standard opioid prescribing. Results may inform wider practice change within both our center, the field of urology, and perhaps surgical care more broadly.

Вмешательства

  • Препарат multimodal analgesia pathway with up-front small opioid prescription
    multimodal analgesia pathway including an up-front small opioid prescription
  • Препарат multimodal analgesia pathway without up-front small opioid prescription
    multimodal analgesia pathway without up-front small opioid prescription
  • Препарат pre-implementation baseline including opioid
    pre-implementation baseline including opioid

Первичные конечные точки

  • Post-discharge opioid consumption (MME) [Срок оценки: 1-2 weeks after surgery]
Вторичные конечные точки (4)
  • Return of bowel function [Срок оценки: 1 week]
  • Emergency Department visits [Срок оценки: 30 days]
  • Postoperative phone calls [Срок оценки: 30 days]
  • Same-day discharge rate [Срок оценки: Day of Surgery]

Критерии участия

Критерии включения

  • Men ≥45 years old
  • Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
  • Able to provide informed consent

Критерии исключения

  • Chronic kidney disease (baseline Cr >1.3)
  • NSAID contraindication/allergy
  • Regular opioid use or substance abuse prior to surgery
  • Inability to provide their own consent
  • Deviation from standard surgical practice for RALP (e.g. major complication requiring operative intervention that would result in patient no longer being considered a routine case)

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
Организация здравоохранения

Центры проведения

США · 2 центра
  • Brigham and Women's Hospital — Boston
  • Brigham and Women's Faulkner Hospital — Boston

Идентификаторы

NCT: NCT07427043 · 2024P001667

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗