Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty

Официальное название

Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if compressive cryotherapy can reduce postoperative opioid consumption in patients undergoing primary total knee arthroplasty. It will also evaluate whether compressive cryotherapy improves postoperative recovery compared with standard care using conventional ice application. The main questions it aims to answer are: Does compressive cryotherapy reduce the total consumption of opioids during the first 7 days after total knee arthroplasty? Does compressive cryotherapy reduce postoperative pain and improve early recovery compared with standard cryotherapy? Researchers will compare compressive cryotherapy using the Game Ready® device with standard care using traditional ice packs to determine whether the intervention reduces opioid consumption and improves postoperative outcomes. Participants will: Be randomly assigned to receive compressive cryotherapy or standard cryotherapy with ice packs after surgery. Apply the assigned treatment four times per day during the first 7 postoperative days. Record daily pain levels using a visual analog scale (VAS) and document opioid consumption in a pain diary. Attend a follow-up visit on postoperative day 7 for evaluation of knee swelling, hematoma size, and recovery using the QoR-15 questionnaire.

Вмешательства

• Устройство Game Ready® compressive cryotherapy device
  The Game Ready® system provides continuous cold water circulation combined with intermittent pneumatic compression using a circumferential wrap applied to the operated knee. The device will be used for 20 minutes per session, four times per day during the first 7 postoperative days after total knee arthroplasty.
• Другое Standard cryotherapy (ice packs)
  Conventional cryotherapy consisting of ice packs applied to the operated knee after surgery according to standard postoperative care. Ice packs will be applied intermittently during the first 7 postoperative days.

Первичные конечные точки

• Total opioid consumption (tramadol tablets) [Срок оценки: First 7 days after surgery]

Вторичные конечные точки (4)

• Postoperative pain intensity measured using the Visual Analog Scale (VAS) [Срок оценки: Daily during the first 7 days after surgery]
• Knee swelling measured by limb circumference [Срок оценки: Baseline (preoperative) and postoperative day 7]
• Hematoma size [Срок оценки: Postoperative day 7]
• Quality of recovery measured with the QoR-15 questionnaire [Срок оценки: Postoperative day 7]

Критерии участия

Критерии включения

• Age between 60 and 80 years
• Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis
• Ability to understand the study procedures and provide written informed consent

Критерии исключения

• Revision total knee arthroplasty
• Vascular disorders affecting the lower limbs
• Body mass index (BMI) greater than 35 kg/m²
• Active knee infection
• Severe preoperative limitations in knee mobility

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

Аргентина · 1 центр

• Hospital Italiano de Buenos Aires — Buenos Aires

Идентификаторы

NCT: NCT07630337 · 7283

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗