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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ivan Huespe, MD
- 電話番号：+543425382554
- メール：ivan.huespe@hospitalitaliano.org.ar
研究場所
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Buenos Aires
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Buenos Aires、Buenos Aires、アルゼンチン、C1181
- 募集
- Hospital Italiano de Buenos Aires
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コンタクト：
- Ivan a Huespe, md
- 電話番号：03425382554
- メール：ivan.huespe@hospitalitaliano.org.ar
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total opioid consumption (tramadol tablets)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative pain intensity measured using the Visual Analog Scale (VAS)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
捜査官
- スタディチェア：Ivan A Huespe, MD、Hospital Italiano de Buenos Aires
- 主任研究者：Igancio Garcia Mansilla, MD、Hospital Italiano de Buenos Aires
- スタディディレクター：Matias Costa Paz, MD、Hospital Italiano de Buenos Aires
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
術後の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了