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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT01673542
• Date of registration: 09/07/2012
• Prospective Registration: Yes
• Primary sponsor: Poitiers University Hospital
• Public title: Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
• Date of first enrolment: August 2012
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01673542
• Study type: Interventional
• Study design: N/A
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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 )



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Surgery Scheduled

Intervention(s)

Drug: Lidocaine-Prilocaine 5%

Drug: DEXERYL

Primary Outcome(s)

Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ® [Time Frame: 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(s)

success [Time Frame: The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic]

evaluation pain [Time Frame: - Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,]

satisfaction [Time Frame: - Assessment of satisfaction of anesthetists]

Secondary ID(s)

EMLAX 2012-001976-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors