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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ivan Huespe, MD
- 전화번호: +543425382554
- 이메일: ivan.huespe@hospitalitaliano.org.ar
연구 장소
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Buenos Aires
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Buenos Aires, Buenos Aires, 아르헨티나, C1181
- 모병
- Hospital Italiano de Buenos Aires
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연락하다:
- Ivan a Huespe, md
- 전화번호: 03425382554
- 이메일: ivan.huespe@hospitalitaliano.org.ar
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total opioid consumption (tramadol tablets)
기간: First 7 days after surgery
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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.
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First 7 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain intensity measured using the Visual Analog Scale (VAS)
기간: Daily during the first 7 days after surgery
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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.
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Daily during the first 7 days after surgery
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Knee swelling measured by limb circumference
기간: Baseline (preoperative) and postoperative day 7
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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.
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Baseline (preoperative) and postoperative day 7
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Hematoma size
기간: Postoperative day 7
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Hematoma size at the surgical site will be assessed on postoperative day 7 using the Fagotti square classification method and recorded in square centimeters.
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Postoperative day 7
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Quality of recovery measured with the QoR-15 questionnaire
기간: Postoperative day 7
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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.
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Postoperative day 7
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires
- 수석 연구원: Igancio Garcia Mansilla, MD, Hospital Italiano de Buenos Aires
- 연구 책임자: Matias Costa Paz, MD, Hospital Italiano de Buenos Aires
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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