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

This study has been completed.
Information provided by (Responsible Party):
Poitiers University Hospital Identifier:
First received: July 9, 2012
Last updated: October 10, 2016
Last verified: October 2016

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 Intervention Phase
Surgery Scheduled Drug: Lidocaine-Prilocaine 5% Drug: DEXERYL Phase 2

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by Poitiers University Hospital:

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

  • satisfaction
    - Assessment of satisfaction of anesthetists

  • 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

Enrollment: 32
Study Start Date: August 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine-Prilocaine 5% Drug: Lidocaine-Prilocaine 5%
Placebo Comparator: Dexeryl Drug: DEXERYL


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01673542

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

Responsible Party: Poitiers University Hospital Identifier: NCT01673542     History of Changes
Other Study ID Numbers: EMLAX 2012-001976-13
Study First Received: July 9, 2012
Last Updated: October 10, 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 processed this record on August 18, 2017