Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty
Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
調査の概要
詳細な説明
Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.
At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).
At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).
Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.
Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.
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
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Hellerup、デンマーク、2900
- Gentofte Hospital
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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 who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
- Written informed consent.
- ASA 1-3
Exclusion Criteria:
- Non-cooperative patients
- Patients who have already had a peripheral or central block post surgery.
- Patients who are not able to perform a TUG test pre surgery.
- Patients who do not understand or speak Danish.
- Patient who are allergic to the drugs used in this research.
- Patients with alcohol- or drug abuse - determined by investigator.
- Patients with peripheral sensory neuropathy in their lower extremities.
- Pregnant patients.
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 |
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アクティブコンパレータ：ACB_active/placebo
Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
他の名前：
他の名前：
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プラセボコンパレーター：ACB_placebo/active
Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
他の名前：
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 |
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Difference between groups in muscle strength of the quadriceps femoris muscle.
時間枠：60 minutes after first ACB (T60)
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Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3
consecutive measurements will be made and the average used.
Results for each group will be presented as percentage of baseline values.
The primary outcome is the difference in MVIC between the groups.
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60 minutes after first ACB (T60)
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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 |
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Difference between groups in muscle strength of the quadriceps femoris muscle.
時間枠：120 minutes after initial ACB (T120)
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Same as primary outcome
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120 minutes after initial ACB (T120)
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VAS pain scores at rest
時間枠：60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
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Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups. VAS pain scores at rest will be inquired before any other outcome measurements. |
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
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VAS pain score during TUG test.
時間枠：60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Timed Up and Go(TUG) test
時間枠：60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Time (seconds) to complete a TUG test measured one hour after the first and second ACB.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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VAS pain scores during 45 degrees active flexion of the knee
時間枠：60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
時間枠：60 minutes after first ACB (T60)
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According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups.
Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm.
Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline?
and is this difference larger in the subgroup of patients scoring VAS 60-100?
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60 minutes after first ACB (T60)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ulrik Grevstad, MD、Gentofte Hospital
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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