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Local Anesthetic
Lidocaine for Pain Control During Endovenous Laser Treatments
N/A
Waitlist Available
Research Sponsored by Midwest Vein Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large Saphenous Vein treatment
Must not have
Liver dysfunction
Patient ineligible for EVLT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing whether a lower concentration of lidocaine in tumescent anesthesia is just as effective as the standard dose for pain management in endovenous laser treatments, in order to reduce the risk of lidocaine toxicity.
Who is the study for?
This trial is for individuals aged 16-85 in good health who require endovenous laser treatment (EVLT) for varicose veins and can understand the consent process. It's not suitable for those with bleeding disorders, lidocaine sensitivity, liver issues, heart failure or if pregnant.
What is being tested?
The study tests whether a lower concentration of lidocaine in tumescent anesthesia is as effective as the standard dose for pain control during and after EVLT. Participants will be randomly assigned to receive either the standard or reduced dose.
What are the potential side effects?
Potential side effects include symptoms related to lidocaine toxicity such as dizziness, numbness, tingling sensations, confusion or seizures if serum levels become too high.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving treatment for my large saphenous vein.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have liver problems.
Select...
I cannot undergo endovenous laser therapy.
Select...
I have a bleeding disorder.
Select...
I have been diagnosed with congestive heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1/4 dose lidocaineExperimental Treatment1 Intervention
12.5mL 1% lidocaine in 487.5mL normal saline
Group II: Standard LidocaineActive Control1 Intervention
50mL 1% lidocaine in 450mL normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved
Find a Location
Who is running the clinical trial?
Midwest Vein CenterLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver problems.I cannot undergo endovenous laser therapy.I have a bleeding disorder.I have been diagnosed with congestive heart failure.I am between 16 and 85 years old and in good health.My doctor says I can have EVLT.I am receiving treatment for my large saphenous vein.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Lidocaine
- Group 2: 1/4 dose lidocaine
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.