Painless Local Infiltration Anesthesia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01611324

Acronym

EASE

Enrollment

100

Registered

2012-06-04

Start date

2012-05-31

Completion date

2012-12-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pain, Surgery, Varicose Veins

Keywords

Varicose Veins, Phlebectomy, Local Anesthesia

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.

Interventions

DRUGMepivacaine 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%

DRUGMepivacaine 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%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026