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

Phase 2

Completed

• Conditions: Surgery Scheduled
• Interventions: Drug: Lidocaine-Prilocaine 5%; Drug: DEXERYL

• Registration Number: NCT01673542
• Lead Sponsor: Poitiers University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2013-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lidocaine-Prilocaine 5%	Lidocaine-Prilocaine 5%	-
Dexeryl	DEXERYL	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
satisfaction		- Assessment of satisfaction of anesthetists
evaluation pain		- Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,
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

Trial Locations

Locations (1)

Service Anesthésie-Réanimation; 🇫🇷 Poitiers, France