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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Poitiers University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01673542
First received: July 9, 2012
Last updated: August 23, 2012
Last verified: July 2012
  Purpose

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


Arms Assigned Interventions
Experimental: Lidocaine-Prilocaine 5% Drug: Lidocaine-Prilocaine 5%
Placebo Comparator: Dexeryl Drug: DEXERYL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 )
  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 ClinicalTrials.gov identifier: NCT01673542

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

No publications provided

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01673542     History of Changes
Other Study ID Numbers: EMLAX 2012-001976-13
Study First Received: July 9, 2012
Last Updated: August 23, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on August 28, 2014