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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01673542
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Surgery Scheduled Drug: Lidocaine-Prilocaine 5% Drug: DEXERYL Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Study Start Date : August 2012
Actual Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lidocaine-Prilocaine 5% Drug: Lidocaine-Prilocaine 5%
Placebo Comparator: Dexeryl Drug: DEXERYL

Primary Outcome Measures :
  1. 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 :
  1. evaluation pain
    - Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,

  2. satisfaction
    - Assessment of satisfaction of anesthetists

  3. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01673542

Service Anesthésie-Réanimation
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

Responsible Party: Poitiers University Hospital Identifier: NCT01673542     History of Changes
Other Study ID Numbers: EMLAX 2012-001976-13
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined