Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks

Study Overview
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Brief Summary
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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

Conditions
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Surgery Scheduled

Intervention / Treatment
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* Drug: Lidocaine-Prilocaine 5%
* Drug: DEXERYL


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine-Prilocaine 5%<br> | Drug: Lidocaine-Prilocaine 5%<br> <br> |
| Placebo Comparator: Dexeryl<br> | Drug: DEXERYL<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ® | 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 |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation pain | - Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm, |  | 
| satisfaction | - Assessment of satisfaction of anesthetists |  | 
| success | The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic |  |