Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration Clinical Trial
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
| NCT number | NCT02192411 |
| Other study ID # | JVDL070714 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | July 14, 2014 |
| Last updated | July 15, 2014 |
| Start date | July 2014 |
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.
| Status | Not yet recruiting |
| Enrollment | 70 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 16 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Midwest Vein Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Midwest Vein Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain | 24 hours | No |