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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: EMLA; Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine

Criteria

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 )