Painless Local Infiltration Anesthesia

Phase 4

Completed

• Conditions: Varicose Veins; Pain; Surgery; Anesthesia
• Interventions: Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%; Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%

• Registration Number: NCT01611324
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-09
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non alkalinised anesthetic solution	Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%	-
Alkalinised anesthetic solution	Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%	-

Primary Outcome Measures

Name	Time	Method
Pain Assessment	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).

Trial Locations

Locations (1)

Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, RM, Italy