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Идёт набор NCT05722002

Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial

Фаза IV С лечением Surgery Pain, Postoperative

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: NSAID, Opioid, Acetaminophen.
Кому может быть актуально
Состояния в реестре: Surgery, Pain, Postoperative. 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, Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This trial is being completed to compare two commonly used options to treat pain after surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen). It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.

Вмешательства

  • Препарат NSAID
    Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Ibuprofen 600 milligram (mg) by mouth every six hours as needed for pain (10 doses) * Celecoxib 400 mg by mouth once then 200 mg every twelve hours as needed for pain (10 doses) * Naproxen 500 mg by mouth once then 250 mg by mouth every eight hours as needed for pain (10 doses)
  • Препарат Opioid
    Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Oxycodone 5 mg by mouth every four to six hours as needed for pain, 10 doses * Morphine 7.5 mg by mouth every four to six hours as needed for pain, 10 doses * Hydromorphone 2 mg by mouth every four to six hours as needed for pain, 10 doses
  • Препарат Acetaminophen
    Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).

Первичные конечные точки

  • Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery [Срок оценки: 7 days post surgery]
  • Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery [Срок оценки: 7 days post surgery]
Вторичные конечные точки (12)
  • Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire [Срок оценки: 1 month post surgery]
  • Clinically important adverse events [Срок оценки: 180 days post surgery]
  • Patient Global Impression of Change (PGIC) [Срок оценки: up to 1 month after surgery]
  • Quality of Recovery (QoR) 15 [Срок оценки: 3 days post surgery]
  • Quality of Recovery (QoR) 15 [Срок оценки: 7 days post surgery]
  • PROMIS Pain Interference 4a [Срок оценки: 3 months]
  • PROMIS Preference score 29+2 Profile v2.1 [Срок оценки: 3 months]
  • Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool [Срок оценки: 180 days post surgery]
  • National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question [Срок оценки: 3 months]
  • National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question [Срок оценки: 180 days]
  • New prolonged opioid use [Срок оценки: days 4-180 post surgery]
  • Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery [Срок оценки: 180 days post surgery]

Критерии участия

Критерии включения

  • No significant analgesic medication use before surgery: For this study, significant analgesic medication use before surgery as use of prescriptions for opioid or NSAID medications in the past 30 days, or over-the-counter NSAID use on greater than 7 of 30 past days, as reported by the patient.
  • One of three common low-risk surgical procedures: For this study, the three-common low-risk surgical procedures will include laparoscopic gallbladder removal, inguinal hernia repair, and breast lumpectomy.

Критерии исключения

  • Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months
  • Patients with contraindications to NSAID drugs in the NSAID arm, opioid drugs in the OPIOID arm, or acetaminophen will be excluded. There are specific contraindications that will be reviewed per protocol.

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 6 центров
  • University of Michigan — Ann Arbor
  • Henry Ford Health System — Detroit
  • Washington University in Saint Louis — St Louis
  • Cooper University Health Care — Camden
  • University of North Carolina Hospitals — Chapel Hill
  • Temple University - Temple Health — Philadelphia
Канада · 2 центра
  • Women's College Hospital — Toronto
  • Unity Health Toronto — Toronto

Публикации

  • Bicket MC, Ladha KS, Haroutounian S, McFarlin K, Neff M, McDuffie RL, Waljee JF, Wijeysundera DN, Brummet C, Li Y; CARES Investigators. Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES): protocol for a pragmatic, international multicentre randomised trial. BMJ Open. 2025 Apr 5;15(4):e099925. doi: 10.1136/bmjopen-2025-099925. PMID 40187774

Идентификаторы

NCT: NCT05722002 · HUM00215416 · CER-2021C1-22398

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗