Painless Local Infiltration Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy

Conditions
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Varicose Veins, Pain, Surgery, Anesthesia

Intervention / Treatment
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* Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
* Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ambulatory phlebectomy Exclusion Criteria: Allergy to amide anesthetics Sinoatrial node disease or any degree of atrio-ventricular block Acute diseases Chronic kidney or liver disease Treatment with drugs that alter pain sensitivity (e.g. analgesics) Treatment with monoamine oxidase inhibitors or tricyclic antidepressants Major psychiatric disorders according to DSM IV-TR diagnostic criteria Alcohol abuse actual or recent as described in DSM IV-TR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alkalinised anesthetic solution<br> | Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%<br>* 4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%<br>* Other names: Carbosen© 2%;|
| Active Comparator: Non alkalinised anesthetic solution<br> | Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%<br>* 4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%<br>* Other names: Carbosen© 2%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment | 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). | Initial 2 minutes of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins, Phlebectomy, Local Anesthesia