オピオイドを使用しない整形外科
マルチモーダルなオピオイドを使用しない整形外科手術を調べる二重盲検無作為対照試験
The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- Emory University Hospital
-
Atlanta、Georgia、アメリカ、30029
- The Emory Clinic
-
Tucker、Georgia、アメリカ、30084
- Emory Orthopedic and Spine Hospital
-
-
参加基準
適格基準
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:
- Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
- Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
- Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
- Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
- Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent
Exclusion Criteria:
- Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
- Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
- Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
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：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Opioid Group
Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain |
Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed |
|
実験的：Placebo Group
Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain |
Encapsulated placebo tablets x24, to take po q6 hours as need for pain |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Pain (VAS) Score
時間枠：Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative
|
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months and 24 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating. |
Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Opioid Consumption
時間枠：Postoperative Days 1-14
|
Total opioid consumption in Morphine milligram equivalents (MME) during the first 2 weeks after surgery will be measured. |
Postoperative Days 1-14
|
|
Number of participants that required Rescue Opioid Prescription
時間枠：Postoperative Days 1-14
|
Number of participants that required the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks. |
Postoperative Days 1-14
|
|
Number of tables consumed as Rescue Opioid
時間枠：Postoperative Days 1-14
|
Number of tablets taken from the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks. |
Postoperative Days 1-14
|
|
Number of Additional Opioid Prescription Refills
時間枠：Postoperative Days 1-14
|
Number of additional opioid prescription refills required during the postoperative period. |
Postoperative Days 1-14
|
|
Number of participants experiencing Postoperative Nausea
時間枠：Three times a day postoperatively for the first 2 weeks
|
Number of participants experiencing nausea during the postoperative period. This scale will assess nausea at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The scale will range from 0-10 with 10 being a worse outcome quantifying the highest nausea rating. |
Three times a day postoperatively for the first 2 weeks
|
|
Hand/Wrist function Measured by the Single Assessment Numeric Evaluation (SANE)
時間枠：Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
|
The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. A rating of 0 is the minimum value and denotes the worse outcome a patient can have on the scale. |
Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
|
|
Upper Extremity Function Measured by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
時間枠：Baseline (Preoperative); and at 12 and 24 months postoperatively.
|
Upper extremity disability will be assessed using the QuickDASH questionnaire. Scores range from 0 to 100, with lower scores indicating less disability. |
Baseline (Preoperative); and at 12 and 24 months postoperatively.
|
|
Overall Satisfaction with the procedure and Pain Management
時間枠：12 and 24 months postoperatively
|
Overall satisfaction with the surgical procedure and postoperative pain management will be assessed using a patient-reported 5-point rating scale. Participants will select one of the following responses: "Very satisfied", "satisfied", "neutral", "dissatisfied", and "Very dissatisfied". Responses are assigned a score from 1 to 5, where 1 corresponds to "very dissatisfied" and 5 corresponds to "very satisfied". Higher scores indicate greater satisfaction and better perceived outcomes |
12 and 24 months postoperatively
|
|
Willingness to undergo the same procedure with the same pain management
時間枠：12 and 24 months postoperatively
|
Number of Participants that confirm their willingness to undergo the same procedure again using the same postoperative pain management regimen. |
12 and 24 months postoperatively
|
|
Number of participants Experiencing Major Postoperative Complications
時間枠：From surgery through 24 months postoperatively
|
Number of participants experiencing one or more major postoperative complications, including temporary or permanent nerve injury, hematoma, superficial or deep infection, recurrent moderate or severe pain, fracture, implant loosening, dislocation, or revision surgery. |
From surgery through 24 months postoperatively
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Eric Wagner, MD、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- STUDY00000478
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国で製造され、米国から輸出された製品。
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