A Pilot Randomized Controlled Trial of Suzetrigine as an Adjunct to Multimodal Analgesia Following Total Knee Arthroplasty
This proposal seeks to determine if the addition of Suzetrigine, a novel non-opioid pain medication, to a standardized multimodal pain management pathway significantly reduces total postoperative opioid consumption (measured in Morphine Milligram Equivalents [MME]) and improves patient-reported pain scores during the first 14 days following primary total knee arthroplasty (TKA). Prior to conducting a definitive randomized control trial (RCT), we propose a pilot study to inform the trial's design and feasibility.
Objective: To inform the design and feasibility of a definitive RCT comparing postoperative pain control with and without Suzetrigine after TKA. To achieve this objective, we will conduct a pilot trial and address the following aims:
1) to determine if participant enrollment is feasible, 2) to assess compliance with treatment protocol and key aspects of the protocol, and 3) to refine data collection methods.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Peter Hsiue, MD
- 電話番号：714-456-7012
- メール：phsiue@hs.uci.edu
研究連絡先のバックアップ
- 名前：Steven Yang, MD
- 電話番号：714-456-7012
- メール：stevey1@hs.uci.edu
研究場所
-
-
California
-
Orange、California、アメリカ、92868
- UCI Health Medical Center
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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:
- Adults aged 18 to 80 years
- Diagnosis of knee osteoarthritis
- Scheduled for unilateral TKA
- Willingness to maintain a 14-day medication and pain log
Exclusion Criteria:
- Chronic opioid use
- Severe renal impairment (eGFR < 30 mL/min) or severe hepatic impairment (Child-Pugh Class C)
- History of active peptic ulcer disease or GI bleeding
- Known allergies to any of the study medications (suzetrigine, acetaminophen, meloxicam, or oxycodone).
- Significant peripheral neuropathy in the operative extremity
- Active history of substance abuse or opioid use disorder
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 |
|---|---|
|
介入なし：Standard Multimodal Group
Standard multimodal control group will receive treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed). |
|
|
実験的：Suzetrigine Group
The Suzetrigine group will receive a 100 mg loading dose of Suzetrigine, followed by 50mg Q12h for 14 days as an addition to a standardized multimodal pain management pathway. The standardized multimodal pain management pathway consists of treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed). |
100 mg loading dose of Suzetrigine, followed by 50mg every 12 hours for 14 days as an addition to a standardized multimodal pain management pathway. |
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 |
|---|---|---|
|
Participant enrollment
時間枠：At enrollment
|
Enrollment rates |
At enrollment
|
|
Protocol adherence
時間枠：Within 14 days
|
Protocol adherence rates |
Within 14 days
|
|
Data collection
時間枠：At 14 days
|
Completeness of data collection |
At 14 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Clinical Outcome: Opioid consumption
時間枠：Within 14 days
|
Total cumulative opioid consumption in milligrams morphine equivalents (MME) within the study period |
Within 14 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain
時間枠：At 14 days
|
Numeric Pain Rating Scale (NPRS): Zero is equivalent to no pain and 10 indicates the worst possible pain. |
At 14 days
|
|
First day of walking unassisted
時間枠：Within 14 days
|
Within 14 days
|
|
|
Barthel Index for Activities of Daily Living (ADL)
時間枠：At 14 days
|
Cumulative score ranges from 0 to 100, where 0 indicates complete dependence and 100 signifies total independence |
At 14 days
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
時間枠：At 14 days
|
0 represents extreme knee problems, and 100 represents no knee problems |
At 14 days
|
|
Knee range of motion
時間枠：At 14 days
|
Clinical assessment |
At 14 days
|
|
Time to opioid cessation
時間枠：Within 14 days
|
Within 14 days
|
|
|
Opioid prescription renewal
時間枠：Within 14 days
|
Within 14 days
|
|
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Incidence of opioid-related adverse events
時間枠：Within 14 days
|
Within 14 days
|
協力者と研究者
捜査官
- 主任研究者：Peter Hsiue, MD、University of California, Irvine
- 主任研究者：Steven Yang, MD、University of California, Irvine
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
その他の研究ID番号
- STUDY00001001
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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