Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial
Information source: Midwest Vein Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration
Intervention: Lidocaine (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Midwest Vein Center Overall contact:
Deborah S Lindner, MD, Phone: 3127183051, Email: deborahsuemd@gmail.com
Summary
Endovenous laser treatment is a minimally invasive procedure that has been shown to be a
safe and effective treatment for varicose veins. Essential to the successful ablation of
refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. One of
the components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While
lidocaine can be used safely as long as serum concentrations remain low, its use carries the
risk of lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is
desirable to use the minimum effective concentration of lidocaine needed to manage pain
during a procedure. This study seeks to determine if a ¼ lower concentration of lidocaine
in tumescent anesthesia will function as well as the standard dose for pain management in
endovenous laser treatments. If we find that this is the case, we will be able to reduce the
risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while
maintaining their comfort throughout the procedure. This will be achieved through a direct
comparison of intra- and post-operative pain for patients randomized to receive either the ¼
tumescent lidocaine concentration or the standard lidocaine concentration.
Clinical Details
Official title: Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; a Double Blinded, Randomized, Controlled Non-inferiority Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Pain
Eligibility
Minimum age: 16 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Large Saphenous Vein treatment
- 16-85 years old, good health
- Able to understand informed consent
- Eligible for EVLT determined by physician
Exclusion Criteria:
- Patients with know lidocaine sensitivity
- Bleeding disorders
- Pregnancy
- Congestive heart failure
- Liver dysfunction
- Patient ineligible for EVLT
Locations and Contacts
Deborah S Lindner, MD, Phone: 3127183051, Email: deborahsuemd@gmail.com
Midwest Vein Center, Chicago, Illinois 60611, United States; Not yet recruiting
Deborah S Lindner, MD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: July 15, 2014
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