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
- 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
- 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
- successThe success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic
|Study Start Date:||August 2012|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Lidocaine-Prilocaine 5%||Drug: Lidocaine-Prilocaine 5%|
|Placebo Comparator: Dexeryl||Drug: DEXERYL|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673542
|Poitiers, France, 86021|