Varices according to the CEAP classification
Conditions
Interventions
Trade Name: Lidocaine injections
Product Name: lidocaine
Product Code: N01BB02
Pharmaceutical Form: Infusion
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing ambulatory phlebectomy aged > 18years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 109 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (eg. analgesics) • Treatment with monoamine oxidase inhibitors or tricyclic antidepressants • Major psychiatric disorders according to DSM IV-TR diagnostic criteria • Alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate benefits in alleviating pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures, by diluting a 2% lidocaine+epinephrine anesthetic solution with 1.4% sodium bicarbonate;Secondary Objective: Complication;Primary end point(s): VAS-analoque pain score;Timepoint(s) of evaluation of this end point: Preoperative, peroperative, postoperative, day 1, day 2 and 1-2 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complication Full recovery;Timepoint(s) of evaluation of this end point: 2 weeks, 3-6Months | — |
Countries
Netherlands
Outcome results
None listed