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Набор по приглашению NCT06561035

ACL-R Opioid Sparing Study

Фаза III С лечением Anterior Cruciate Ligament Injuries

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: Opiate Sparing, Opiate Based.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Injuries. Базовые параметры: 14 лет — 85 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

Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery

Обзор

This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Подробное описание

There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure (Shah et al., 2019). Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions (Volkow et al., 2011), surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries (Gazendam et al., 2022; Jones et al., 2022). Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction.

The purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.

Вмешательства

  • Препарат Opiate Sparing
    Subjects will receive medications in the Opiate Sparing arm for pain control.
  • Препарат Opiate Based
    Subjects will receive medications in the Opiate Based arm for pain control.

Первичные конечные точки

  • Visual Analog Scale [Срок оценки: Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.]
  • Oral morphine equivalent [Срок оценки: daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.]
Вторичные конечные точки (1)
  • Incidence of treatment-emergent adverse event. [Срок оценки: From day of surgery to 12-week follow up visit.]

Критерии участия

Критерии включения

  • 14-85 years of age.
  • Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.
  • Patients weigh at least 90lbs at time of enrollment.
  • Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).
  • Willing and able to provide written informed consent.
  • Willing and able to cooperate with postoperative therapy.
  • Speak and read fluent English.

Критерии исключения

  • Multiligament knee reconstruction.
  • Pre-injury opioid consumption.
  • Substance abuse disorder (illicit drug abuse, alcoholism, etc).
  • Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).
  • Chronic pain syndrome.
  • Renal disease.
  • Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors.
  • Known sensitivity, allergy, or intolerance to medications within protocols.
  • History of diabetes.
  • Currently taking glucagon-like peptide 1 agonist.
  • Female patient who is pregnant on day of surgery or becomes pregnant during study period.

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
  • Campbell Clinic — Memphis

Идентификаторы

NCT: NCT06561035 · 24-09976-FB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗