Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial

Status unconfirmed · Not applicable

Conditions studied: Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration

In brief

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.

Key facts

Study ID

NCT02192411

Run by

Midwest Vein Center

People needed

70

Starts

2014-07-01

Last updated by the study team

2014-07-16

Who can join

Age: 16 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Large Saphenous Vein treatment
• 16-85 years old, good health
• Able to understand informed consent
• Eligible for EVLT determined by physician

You may not qualify if…

• Patients with know lidocaine sensitivity
• Bleeding disorders
• Pregnancy
• Congestive heart failure
• Liver dysfunction
• Patient ineligible for EVLT

Where it is running

• Midwest Vein Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.