Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial
Status: | Not yet recruiting |
---|---|
Healthy: | No |
Age Range: | 16 - 85 |
Updated: | 4/2/2016 |
Start Date: | July 2014 |
Contact: | Deborah S Lindner, MD |
Email: | deborahsuemd@gmail.com |
Phone: | 3127183051 |
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
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials