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Completed

NCT Number: NCT01673542

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

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

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Key information

Conditions

Surgery Scheduled

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service Anesthésie-Réanimation

Poitiers, 86021, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Lidocaine-Prilocaine 5%

Drug

DEXERYL

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
First posted
Aug 28, 2012
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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