Clinical trial NCT01611324: Painless Local Infiltration Anesthesia
Official title: Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Veins
Pain
Surgery
Anesthesia
Keywords: Varicose Veins
Phlebectomy
Local Anesthesia
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Assessment
timeFrame: Initial 2 minutes of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
state: RM
Study officials:
affiliation: University Campus Bio-Medico
name: Stefano Ricci, M.D.
role: STUDY_CHAIR
affiliation: University Campus Bio-Medico
name: Leo Moro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Campus Bio-Medico
name: Francesco Maria Serino, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Campus Bio-Medico
name: Raffaele Antonelli Incalzi, M.D.
role: STUDY_DIRECTOR
References:
citation: Creton D, Rea 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.