Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty
Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ivan Huespe, MD
- 电话号码：+543425382554
- 邮箱：ivan.huespe@hospitalitaliano.org.ar
学习地点
-
-
Buenos Aires
-
Buenos Aires、Buenos Aires、阿根廷、C1181
- 招聘中
- Hospital Italiano de Buenos Aires
-
接触：
- Ivan a Huespe, md
- 电话号码：03425382554
- 邮箱：ivan.huespe@hospitalitaliano.org.ar
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Compressive Cryotherapy
Participants assigned to this arm will receive compressive cryotherapy using the Game Ready® device after primary total knee arthroplasty.
The device delivers circulating cold water combined with intermittent pneumatic compression.
Cryotherapy will be applied for 20 minutes, four times per day, during the first 7 postoperative days.
Compression will not be applied during the first two postoperative days and will be applied at medium pressure from postoperative day 3 to day 7.
All participants will also receive the standard postoperative analgesia and rehabilitation protocol.
|
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.
|
|
有源比较器：Standard Cryotherapy (Ice Packs)
Participants assigned to this arm will receive standard postoperative care consisting of conventional cryotherapy using ice packs applied to the operated knee as needed during the first 7 postoperative days.
Participants will also be advised to elevate the operated limb to help control postoperative swelling.
All participants will receive the same postoperative analgesia and rehabilitation protocol as the intervention group.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total opioid consumption (tramadol tablets)
大体时间：First 7 days after surgery
|
Total number of tramadol tablets (50 mg each) consumed by participants during the first 7 postoperative days after primary total knee arthroplasty.
Participants will record daily tramadol consumption in a pain diary, and the total number of tablets used during the study period will be calculated.
|
First 7 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain intensity measured using the Visual Analog Scale (VAS)
大体时间：Daily during the first 7 days after surgery
|
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Participants will record daily pain scores in a pain diary during the first postoperative week.
|
Daily during the first 7 days after surgery
|
|
Knee swelling measured by limb circumference
大体时间：Baseline (preoperative) and postoperative day 7
|
Postoperative swelling will be assessed by measuring limb circumference 10 cm proximal to the superior pole of the patella and 10 cm distal to the inferior pole of the patella.
Measurements will be compared with preoperative baseline values.
|
Baseline (preoperative) and postoperative day 7
|
|
Hematoma size
大体时间：Postoperative day 7
|
Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters.
|
Postoperative day 7
|
|
Quality of recovery measured with the QoR-15 questionnaire
大体时间：Postoperative day 7
|
Patient-reported quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire, which evaluates physical comfort, emotional state, physical independence, psychological support, and pain.
Scores range from 0 to 150, with higher scores indicating better recovery.
|
Postoperative day 7
|
合作者和调查者
合作者
调查人员
- 学习椅：Ivan A Huespe, MD、Hospital Italiano de Buenos Aires
- 首席研究员：Igancio Garcia Mansilla, MD、Hospital Italiano de Buenos Aires
- 研究主任：Matias Costa Paz, MD、Hospital Italiano de Buenos Aires
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.