NCT01611324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

May 17, 2012

Last Update Submit

December 9, 2012

Conditions

Varicose VeinsPainSurgeryAnesthesia

Keywords

Varicose VeinsPhlebectomyLocal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Alkalinised anesthetic solution

EXPERIMENTAL
Drug: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%

Non alkalinised anesthetic solution

ACTIVE COMPARATOR
Drug: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%

Interventions

Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%DRUG

4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%

Also known as: Carbosen© 2%
Alkalinised anesthetic solution
Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%DRUG

4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%

Also known as: Carbosen© 2%
Non alkalinised anesthetic solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing ambulatory phlebectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Universitario Campus Bio-Medico

Rome, RM, 00128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22106448BACKGROUND

MeSH Terms

Conditions

Varicose VeinsPain

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Stefano Ricci, M.D.

    University Campus Bio-Medico

    STUDY CHAIR

  • Leo Moro, M.D.

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

  • Francesco Maria Serino, M.D.

    University Campus Bio-Medico

    PRINCIPAL INVESTIGATOR

  • Raffaele Antonelli Incalzi, M.D.

    University Campus Bio-Medico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2012

First Posted

June 4, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

IT(1)