Painless Local Infiltration Anesthesia (EASE)
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|ClinicalTrials.gov Identifier: NCT01611324|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|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%
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|