Painless Local Infiltration Anesthesia (EASE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raffaele Antonelli Incalzi, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01611324
First received: May 17, 2012
Last updated: December 9, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Varicose Veins
Pain
Surgery
Anesthesia
Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy

Resource links provided by NLM:


Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Pain Assessment [ Time Frame: Initial 2 minutes of the procedure ] [ Designated as safety issue: No ]
    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).


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alkalinised anesthetic solution 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%
Other Name: Carbosen© 2%
Active Comparator: Non alkalinised anesthetic solution 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%
Other Name: Carbosen© 2%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611324

Locations
Italy
Policlinico Universitario Campus Bio-Medico
Rome, RM, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Study Chair: Stefano Ricci, M.D. University Campus Bio-Medico
Principal Investigator: Leo Moro, M.D. University Campus Bio-Medico
Principal Investigator: Francesco Maria Serino, M.D. University Campus Bio-Medico
Study Director: Raffaele Antonelli Incalzi, M.D. University Campus Bio-Medico
  More Information

Publications:
Responsible Party: Raffaele Antonelli Incalzi, Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01611324     History of Changes
Other Study ID Numbers: EASE
Study First Received: May 17, 2012
Last Updated: December 9, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Campus Bio-Medico University:
Varicose Veins
Phlebectomy
Local Anesthesia

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Mepivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on September 18, 2014