Painless Local Infiltration Anesthesia (EASE)
|Varicose Veins Pain Surgery Anesthesia||Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4% Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy|
- Pain Assessment [ Time Frame: Initial 2 minutes of the procedure ]Pain severity will be rated by the subjects on a visual analog scale, after the first five injections (placement of the needle + administration of anesthetic solution).
|Study Start Date:||May 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Alkalinised anesthetic solution||
Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%
Other Name: Carbosen© 2%
|Active Comparator: Non alkalinised anesthetic solution||
Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%
Other Name: Carbosen© 2%
The use of local anesthesia by infiltration (LIA), usually prepared with 1% lidocaine or mepivacaine 2%, in combination with epinephrine and diluted with saline solution, it's commonly performed in ambulatory phlebectomy procedures.
Although this kind of anesthesia is among the most effective and safe available, the infiltration of local anesthetic is accompanied by pain in the majority of patients. This can be particularly important in ambulatory phlebectomy procedures, where large areas need to be anesthetized.
Numerous methods have been proposed to alleviate the pain associated with LIA, such as reducing the rate of administration or warming the anesthetic solution.
Sodium bicarbonate added in small concentrations, can also be effective in reducing significantly the pain associated with LIA. A recent trial has confirmed the viability and effectiveness of a solution of lidocaine 1% diluted in sodium bicarbonate 1.4%, in varicose vein surgery.
The purpose of this study is to evaluate the effectiveness in alleviating the pain associated with LIA, of a solution of mepivacaine 2%+epinephrine diluted with sodium bicarbonate 1.4%, compared with an analogous solution diluted with normal saline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611324
|Policlinico Universitario Campus Bio-Medico|
|Rome, RM, Italy, 00128|
|Study Chair:||Stefano Ricci, M.D.||University Campus Bio-Medico|
|Principal Investigator:||Leo Moro, M.D.||University Campus Bio-Medico|
|Principal Investigator:||Francesco Maria Serino, M.D.||University Campus Bio-Medico|
|Study Director:||Raffaele Antonelli Incalzi, M.D.||University Campus Bio-Medico|