一次人工膝関節全置換術における痛みの軽減におけるベンラファキシンの使用
一次人工膝関節全置換術における手術後の急性疼痛およびオピオイド消費の軽減におけるベンラファキシンの使用
Patients experience pain after their knee replacement surgery - and some may continue to experience persistent pain long after their knee replacement surgery. Traditional pain management strategies reply on pain medication such as opioids for pain control. However, these drugs do not work well for pain associated with movement or the the nerve pain (tingling, electrical sensations) after surgery. In addition, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, depression, cognitive dysfunction and risk of persistent opioid use. Neuropathic pain medications, such as venlafaxine are effective in managing nerve pain. Recent studies also support its potential role in acute pain management. Here, we propose a prospective randomized clinical trial 1) to evaluate the efficacy of Venlafaxine in reducing pain intensity and opioid consumption at post-operative day 1 (POD1) and 1- week after surgery, and 2) to examine whether the use of Venlafaxine will reduce the incidents of chronic postsurgical pain in TKA patients at 3-month time point.
調査の概要
詳細な説明
Patients meeting the inclusion criteria will be randomized to receive either Venlafaxine extended release (ER) 37.5 mg/d or a placebo on the day of surgery and continue the treatment for 7 days after surgery. The primary outcomes include pain severity score (numeric rating scale, NRS) and consumption of morphine miligram equivalent (MME) at 24 hours. The secondary outcome will measure MME and NRS at postoperative day 7. In addition, the disability scale and perceived function 3 months after surgery will be compared to the baseline level by using PROMIS (Patient-Reported Outcomes Measurement Information System)10 Global Health, KOOS, JR. (Knee injury and Osteoarthritis Outcome Score Short Form), and VR-12 (Veterans RAND 12 Item Health Survey) Scale.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California San Francisco
-
-
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:
- adult (male and female) subjects aged 18 to 75,
- English speaking,
- are scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal.
Exclusion Criteria:
- general anesthesia,
- hepatic & renal failure,
- history of diabetic peripheral neuropathic pain,
- chronic opioid use,
- concurrent use of antidepressants, triptans, and/or linezolid,
- allergy to the study medications,
- prior knee surgery,
- BMI > 40,
- bleeding disorders,
- history of recent falls,
- concurrent benzodiazepine use.
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery. |
placebo filled pill daily for 7 consecutive days.
他の名前：
|
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実験的：Venlafaxine
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery. |
venlafaxine 37.5mg daily for 7 consecutive days.
他の名前：
|
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 |
|---|---|---|
|
Total Opioid Consumption on Postoperative Day 1
時間枠：Postoperative Day 1
|
Total opioid consumption measured in morphine milligram equivalents (MME) on postoperative day 1. |
Postoperative Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NRS Pain Score at Postoperative Day 1
時間枠：Postoperative Day 1
|
Pain Scores will be measured on the Numerical Rating Scale (NRS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. |
Postoperative Day 1
|
|
BPI Pain Interference Score at Postoperative Day 7
時間枠：Postoperative Day 7
|
The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. |
Postoperative Day 7
|
|
Pain Severity and Interference at 3 Months Post Operatively
時間枠：3 months
|
The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. |
3 months
|
|
Opioid Consumption at 7 Days Postoperatively
時間枠：7 days
|
morphine miligram equivalent |
7 days
|
|
Functionality at 3 Months - KOOS Short Form
時間枠：3 months
|
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS-12), a 12-item patient-reported questionnaire assessing knee-related quality of life. Scored 0-100 where 0 = extreme knee problems and 100 = no knee problems. Higher scores represent better knee function. Values reported as change from baseline to 3 months postoperatively (3-month score minus baseline score); higher change scores indicate greater improvement. Assessed at baseline and 3 months postoperatively. |
3 months
|
|
Number of Participants Consuming Opioids at 3 Months
時間枠：3 months
|
number of participants who reported consuming opioids at the 3-month follow-up. |
3 months
|
|
Patient Satisfaction With Pain Control
時間枠：Postoperative Days 1, 2, 7, and 3 months
|
Patient satisfaction with pain control measured on a 0-100 visual analog scale, where 0 = completely dissatisfied and 100 = completely satisfied. Assessed at POD1, POD2, POD7, and 3 months postoperatively. Values represent model-predicted means from mixed-effects repeated measures analysis. |
Postoperative Days 1, 2, 7, and 3 months
|
|
Functionality at 3 Months - PROMIS Global-10
時間枠：3 months
|
PROMIS Global-10 (Patient-Reported Outcomes Measurement Information System), reported as T-scores standardized to the US general population (mean=50, SD=10). Four subscores reported separately: Global Mental Health (GMH), Global Physical Health (GPH), Mental Component Score (MCS), and Physical Component Score (PCS). For all subscores, higher T-scores represent better health outcomes. Values reported as change from baseline to 3 months postoperatively (3-month score minus baseline score); higher change scores indicate greater improvement. Assessed at baseline and 3 months postoperatively. |
3 months
|
協力者と研究者
捜査官
- 主任研究者：Matthias Behrends, MD、University of California, San Francisco
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
- 20-32595
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?
IPD プランの説明
We will share our raw clinical data with other researchers.
IPD 共有時間枠
For the entire study period
IPD 共有アクセス基準
Non-profit and research purpose.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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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