Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
調査の概要
詳細な説明
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.
Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.
Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.
The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.
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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Texas
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Dallas、Texas、アメリカ、75390
- UTSW Parkland Health Hospital System
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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:
- Female ASA physical status 1-3 scheduled for total hip arthroplasty
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
Exclusion Criteria:
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Significant psychiatric disturbance
- Inability to understand the study protocol
- Refusal to provide written 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: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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アクティブコンパレータ:Compartment Block
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
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Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
0.5 mg epinephrine
他の名前:
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アクティブコンパレータ:Infiltration
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
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Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
0.5 mg epinephrine
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 |
|---|---|---|
|
Postoperative Pain Score at Resting
時間枠:Postoperative 48 hours
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The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
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Postoperative 48 hours
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Postoperative Pain Score With Movement
時間枠:Postoperative 48 hours
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The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
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Postoperative 48 hours
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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 |
|---|---|---|
|
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
時間枠:Postoperative 48 hours
|
Total amounts of postoperative opioid requirements for 48 hours postoperatively
|
Postoperative 48 hours
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The Time to Ambulation
時間枠:Postoperative 48 hours
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The time to ambulation during 48 hours postoperative period
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Postoperative 48 hours
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協力者と研究者
捜査官
- 主任研究者:Irina Gasanova, MD、UT Southwestern Medical Center
出版物と役立つリンク
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 (見積もり)
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
- STU 122015-022
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?
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