Painless Local Infiltration Anesthesia

Pain Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611324
• Other study ID #: EASE
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2012
• Last updated: December 9, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Pain
• Surgery
• Varicose Veins

Intervention

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%
• 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%

Locations

Country	Name	City	State
Italy	Policlinico Universitario Campus Bio-Medico	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Creton D, Réa B, Pittaluga P, Chastanet S, Allaert FA. Evaluation of the pain in varicose vein surgery under tumescent local anaesthesia using sodium bicarbonate as excipient without any intravenous sedation. Phlebology. 2012 Oct;27(7):368-73. doi: 10.1258/phleb.2011.011026. Epub 2011 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No