変形性膝関節症に対するコルチコステロイド注射に最適な麻酔薬 (Injections)
変形性膝関節症に対するコルチコステロイド注射に最適な麻酔薬。
To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).
調査の概要
詳細な説明
Primary objective is to evaluate pain relief from corticosteroids, Kenalog without anesthetic as well as with different volumes of anesthetic. The investigators will measure the VAS pain score at the time of the injection as well as several time points following the injection. Additionally, the investigators will evaluate how long the injection provided pain relief for the patient.
The secondary intend is to evaluate how well the patients tolerate Kenalog mixtures without anesthetic as well as with different volumes of anesthetic by using the VAS pain scale.
The investigators hypothesize that patient with lower volume of injection will experience less pain during the procedure and that there will be no statistically significant difference in pain level between the study groups during the study period.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Florida
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Tampa、Florida、アメリカ、33637
- Florida Orthopaedic Institute
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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:
- Patients must be 18 years of age and be able to consent for themselves.
- OA grade Kellgren Lawrence Stage II or III.
- Diagnosis of primary osteoarthritis.
Exclusion Criteria:
- Patients with other forms of arthritis such as inflammatory arthritis.
- History of narcotic use for the past 6 months.
- Kellgren Lawrence arthritis grade 1 or 4.
- Pregnant women and prisoners.
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：独身
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：Kenalog with 0ml bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
他の名前：
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実験的：Kenalog with 4ml bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
他の名前：
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実験的：Kenalog with 0.25% bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
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 |
|---|---|---|
|
Injection for Knee Pain
時間枠：Prior to procedure (in office)
|
Visual Analogue Scale (VAS) |
Prior to procedure (in office)
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Injection for Knee Pain
時間枠：Immediate post procedure (in office)
|
Visual Analogue Scale (VAS) |
Immediate post procedure (in office)
|
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Injection for Knee Pain
時間枠：2 minutes post procedure (in office)
|
Visual Analogue Scale (VAS) |
2 minutes post procedure (in office)
|
|
Injection for Knee Pain
時間枠：Day 1 post procedure (phone interview)
|
Visual Analogue Scale (VAS) |
Day 1 post procedure (phone interview)
|
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Injection for Knee Pain
時間枠：Day 14 post procedure (through EDC)
|
Visual Analogue Scale (VAS) |
Day 14 post procedure (through EDC)
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Injection for Knee Pain
時間枠：Day 42 post procedure (in office)
|
Visual Analogue Scale (VAS) |
Day 42 post procedure (in office)
|
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Injection for Knee Pain
時間枠：Day 84 post procedure (through EDC)
|
Visual Analogue Scale (VAS) |
Day 84 post procedure (through EDC)
|
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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Assessment of Knee Pain
時間枠：Immediate Post-op (in office)
|
Global Perceived Improvement |
Immediate Post-op (in office)
|
|
Assessment of Knee Pain
時間枠：Day 1 post procedure (phone interview)
|
Global Perceived Improvement |
Day 1 post procedure (phone interview)
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Assessment of Knee Pain
時間枠：Day 42 post procedure (in office)
|
Global Perceived Improvement |
Day 42 post procedure (in office)
|
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Assessment of Knee Pain
時間枠：Day 84 post procedure (through EDC)
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Global Perceived Improvement |
Day 84 post procedure (through EDC)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Medications
時間枠：Prior to procedure (in office)
|
Review of Medications |
Prior to procedure (in office)
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Medications
時間枠：Day 1 post procedure (phone interview)
|
Review of Medications |
Day 1 post procedure (phone interview)
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Medications
時間枠：Day 14 post procedure (through EDC)
|
Review of Medications |
Day 14 post procedure (through EDC)
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|
Medications
時間枠：Day 42 post procedure (in office)
|
Review of Medications |
Day 42 post procedure (in office)
|
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Medications
時間枠：Day 84 post procedure (through EDC)
|
Review of Medications |
Day 84 post procedure (through EDC)
|
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Review of Adverse Events
時間枠：Immediate post procedure (in office)
|
Any issues with procedure |
Immediate post procedure (in office)
|
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Review of Adverse Events
時間枠：Day 1 post procedure (phone interview)
|
Any issues with procedure |
Day 1 post procedure (phone interview)
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Review of Adverse Events
時間枠：Day 42 post procedure (in office)
|
Any issues with procedure |
Day 42 post procedure (in office)
|
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Review of Adverse Events
時間枠：Day 84 post procedure (through EDC)
|
Any issues with procedure |
Day 84 post procedure (through EDC)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Bedard NA, Dowdle SB, Anthony CA, DeMik DE, McHugh MA, Bozic KJ, Callaghan JJ. Response to Letter to the Editor on "The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty?". J Arthroplasty. 2018 Jan;33(1):307. doi: 10.1016/j.arth.2017.10.002. Epub 2017 Oct 10. No abstract available.
- Blankstein M, Lentine B, Nelms NJ. Common Practices in Intra-Articular Corticosteroid Injection for the Treatment of Knee Osteoarthritis: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2021 Mar;36(3):845-850. doi: 10.1016/j.arth.2020.09.022. Epub 2020 Oct 8.
- Grishko V, Xu M, Wilson G, Pearsall AW 4th. Apoptosis and mitochondrial dysfunction in human chondrocytes following exposure to lidocaine, bupivacaine, and ropivacaine. J Bone Joint Surg Am. 2010 Mar;92(3):609-18. doi: 10.2106/JBJS.H.01847.
- Smith MD, Wetherall M, Darby T, Esterman A, Slavotinek J, Roberts-Thomson P, Coleman M, Ahern MJ. A randomized placebo-controlled trial of arthroscopic lavage versus lavage plus intra-articular corticosteroids in the management of symptomatic osteoarthritis of the knee. Rheumatology (Oxford). 2003 Dec;42(12):1477-85. doi: 10.1093/rheumatology/keg398. Epub 2003 Jul 16.
- Parker RD, Streem K, Schmitz L, Martineau PA; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-6. doi: 10.1177/0363546506296313. Epub 2007 Jan 23.
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
- PI_ PAL_V3_ 8
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
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