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Painless Local Infiltration Anesthesia

NCT01611324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-12-11

No results posted yet for this study

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.

Conditions

  • Varicose Veins
  • Pain
  • Surgery
  • Anesthesia

Interventions

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%

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%

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Stefano Ricci, M.D. · University Campus Bio-Medico

  • Leo Moro, M.D. · University Campus Bio-Medico

  • Francesco Maria Serino, M.D. · University Campus Bio-Medico

  • Raffaele Antonelli Incalzi, M.D. · University Campus Bio-Medico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611324 on ClinicalTrials.gov