The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.
The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.
調査の概要
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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-
-
Copenhagen、デンマーク、2100
- Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia
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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:
- ASA 1
- Body mass index 18-25
Exclusion Criteria:
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
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:クロスオーバー割り当て
- 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 |
---|---|
実験的:ACB with lidocaine 5 mg/ml
Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus
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Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml
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実験的:ACB with lidocaine 15 mg/ml
Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus
|
Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml
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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 |
---|---|---|
Duration of sensory block assessed with pinprick.
時間枠:0-10 hours
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Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour.
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0-10 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 |
---|---|---|
Duration of sensory block assessed by heat pain detection threshold
時間枠:0-10 hours
|
Duration is defined as time from block performance until recovery of normal sensation (+/- 2 degrees Celsius from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.
|
0-10 hours
|
Duration of sensory block assessed by warmth detection threshold
時間枠:0-10 hours
|
Duration is defined as time from block performance until recovery of normal sensation (return to baseline value + 2 degrees Celsius or less from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.
|
0-10 hours
|
Duration of sensory block assessed by pain during 1 minute of warmth stimulation
時間枠:0-10 hours
|
Duration is defined as time from block performance until recovery of normal sensation (return to baseline VAS pain scores +/-10 mm from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.
|
0-10 hours
|
Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation
時間枠:0-10 hours
|
Duration is defined as time from block performance until recovery of normal sensation (return to baseline preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.
|
0-10 hours
|
Duration of sensory block assessed by cold sensation with an alcohol swab
時間枠:0-10 hours
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Duration is defined as time from block performance until recovery of normal sensation assessed at 30 and 60 minutes post block, and thereafter every hour.
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0-10 hours
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Duration of motor block assessed as maximum voluntary isometric contraction.
時間枠:0-10 hours
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Duration is defined as time from block performance until recovery of normal muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour.
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0-10 hours
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Time to onset of sensory block assessed by pinprick.
時間枠:0-2 hours
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Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour.
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0-2 hours
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Jørgen B Dahl, Professor、Rigshospitalet, Denmark
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
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
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
- SM1-PJ-14
- 2014-001752-31 (EudraCT番号)
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