Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.
The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.
Improving professional practice and quality care
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Poitiers、フランス、86021
- Service Anesthésie-Réanimation
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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:
- Age ≥ 18 years
- Hospitalized for upper extremity surgery scheduled
- Having an axillary block anesthesia.
- Free subject, without subordination or guardianship
- Patients undergoing a social security system or benefiting through a third party
- Informed consent and signed by the patient after clear and honest information on the study
Exclusion Criteria:
- Age < 18 years
- Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
- Hypersensitivity to local anesthetics of the amide
- Congenital Methemoglobinemia
- Porphyrias
- Glucose-6-phosphate dehydrogenase
- Hypersensitivity to any component of Dexeryl ®
- Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
- Epilepsy uncontrolled by treatment
- Patients on anticoagulants
- Skin infection from the puncture site
- Patients with psychiatric disorders or dementia
- Cons-indication for infusion Isofundine ®:
- Severe congestive heart failure
- anuria
- oligoanuria
- Fluid retention
- hyperkalemia
- hypercalcemia
- Metabolic alkalosis
- Patients not receiving a social security system or not qualifying through a third party
- People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )
研究計画
研究はどのように設計されていますか？
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Lidocaine-Prilocaine 5%
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プラセボコンパレーター：Dexeryl
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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 |
|---|---|
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Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
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The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
|---|---|
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evaluation pain
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- Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,
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satisfaction
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- Assessment of satisfaction of anesthetists
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success
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The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (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
- EMLAX 2012-001976-13
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