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

NCT01673542 | Completed Phase 2 DMC

• 1 other identifier: EMLAX 2012-001976-13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery Scheduled

Outcome Measures

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 (3)

• evaluation pain

• satisfaction

• success

Study Arms (2)

Lidocaine-Prilocaine 5%

EXPERIMENTAL

Drug: Lidocaine-Prilocaine 5%

Dexeryl

PLACEBO COMPARATOR

Drug: DEXERYL

Interventions

Lidocaine-Prilocaine 5% DRUG

Lidocaine-Prilocaine 5%

DEXERYL DRUG

Dexeryl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Service Anesthésie-Réanimation

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

FR (1)