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

May 17, 2012
December 9, 2012
May 2012
December 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01611324 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Painless Local Infiltration Anesthesia
Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Varicose Veins
  • Pain
  • Surgery
  • Anesthesia
  • 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%
  • 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%
  • Experimental: Alkalinised anesthetic solution
    Intervention: Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
  • Active Comparator: Non alkalinised anesthetic solution
    Intervention: Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01611324
EASE
Yes
Raffaele Antonelli Incalzi, Campus Bio-Medico University
Campus Bio-Medico University
Not Provided
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
Campus Bio-Medico University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP