Pain Clinical Trial
Official title:
Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy
The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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