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

NCT ID: NCT01673542

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

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

Detailed Description

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Conditions

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Surgery Scheduled

Study Groups

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Lidocaine-Prilocaine 5%

Group Type EXPERIMENTAL

Lidocaine-Prilocaine 5%

Intervention Type DRUG

Dexeryl

Group Type PLACEBO_COMPARATOR

DEXERYL

Intervention Type DRUG

Interventions

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Lidocaine-Prilocaine 5%

Intervention Type DRUG

DEXERYL

Intervention Type DRUG

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 )
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Anesthésie-Réanimation

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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EMLAX 2012-001976-13

Identifier Type: -

Identifier Source: org_study_id

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