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

Poitiers University Hospital

Status and phase

Completed

Phase 2

Conditions

Surgery Scheduled

Treatments

Drug: Lidocaine-Prilocaine 5%

Drug: DEXERYL

Study type

Interventional

Funder types

Other

Identifiers

NCT01673542

EMLAX 2012-001976-13

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 )