Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
調査の概要
状態
詳細な説明
Acute pain after a surgical procedure may occur secondary to trauma from the procedure itself or from procedure-related complications. Appropriate peri-operative acute pain management is an important phase of patient's recovery since it's under-treatment can lead to adverse outcomes such as: thromboembolic and pulmonary complications, additional time spent in an intensive care unit or hospital, hospital readmission for further pain management, needless suffering, impairment of health-related quality of life, and development of chronic pain. Furthermore, it's over-treatment with opioid medications is associated with an increased risk of thromboembolic, infectious and gastrointestinal complications as well as increased length of hospital stay, cost of care and risk of opioid addiction.
Perioperative administration of intravenous (IV) non steroidal anti-inflammatory drugs (NSAID), such as ketorolac, has been shown to effectively decrease opioid requirements and pain levels while demonstrating tolerable side effects. Its use after total knee replacement has been associated with a 27% decrease in the use of morphine. When NSAID is combined with acetaminophen 1000mg every six hours, an additional benefit in terms of improved pain scores on post-operative day three was shown in patients who underwent total hip or knee arthroplasty. Therefore, the purpose of this study is to provide an effective alternative for pain management in Hispanic patients who underwent total knee replacement and evaluate the role of ketorolac and acetaminophen.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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San Juan、プエルトリコ、00936
- University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Hispanic American patients undergoing primary total knee arthroplasty
- Older than 21 years of age
- Classified with an American Society of Anesthesiologist Classification (ASA) of I or II.
Exclusion Criteria:
- Hypersensitivity to any components of analgesic drugs
- Impaired renal, cardiac, or hepatic function
- Baseline serum creatinine level higher than 1.2mg/dL
- History of gastrointestinal bleeding
- Neuromuscular deformities
- Inability to consent
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：トリプル
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：Opioid Sparing Multimodal Regimen
After surgery, the experimental group will receive a combination of ketorolac 30 mg intravenous (IV) every six hours for patients younger than 65 years old or ketorolac 15mg IV every six hours for those older than 65 years old; and acetaminophen 1 gram by mouth (PO) every six hours up to 72 hours
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Use of combination of drug dosage frequency and duration of ketorolac injection with acetaminophen oral as standard postoperative pain control for up to 72 hours as requested by each patient
他の名前：
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実験的：Opioid Based Multimodal Regimen
After surgery, the control group will receive a combination of morphine 0.1 mg/kg IV every six hours and oxycodone combined with acetaminophen (2.5 mg / 325 mg) two tabs PO every six hours up to 72 hours
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Use of combination of drug dosage frequency and duration of morphine injection with percocet oral as standard postoperative pain control for up to 72 hours as requested by each patient
他の名前：
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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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Pain scores using numerical rating scale (NRS, 0 to 10)
時間枠：Post-operative 12 hours after surgery
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The amount of pain intensity reported will be measure throughout the numerical rating scale.
Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 12 hours postoperative period
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Post-operative 12 hours after surgery
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Pain scores using numerical rating scale (NRS, 0 to 10)
時間枠：Post-operative 24 hours after surgery
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The amount of pain intensity reported will be measure throughout the numerical rating scale.
Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 24 hours postoperative period
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Post-operative 24 hours after surgery
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Pain scores using numerical rating scale (NRS, 0 to 10)
時間枠：Post-operative 48 hours after surgery
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The amount of pain intensity reported will be measure throughout the numerical rating scale.
Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 48 hours postoperative period
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Post-operative 48 hours 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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Hospital Length of Stay
時間枠：up to 30 days
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The number of days per patient from the time of admission to discharge up to 30 days
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up to 30 days
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Drug-related adverse events
時間枠：From the time of surgery after being discharge (0 to 72 hours after surgery)
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nausea, dizziness, vomit, tachycardia, pruritus and headache
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From the time of surgery after being discharge (0 to 72 hours after surgery)
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協力者と研究者
捜査官
- 主任研究者：Antonio Otero-Lopez, MD、Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B0110219
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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痛みの臨床試験
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Dexa Medica Group完了
Opioid sparing protocolの臨床試験
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Hospital for Special Surgery, New York募集
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Insel Gruppe AG, University Hospital Bern募集
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The Cleveland Clinic終了しました