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

Midwest Vein Center

Status: Unknown

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

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02192411

JVDL070714

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 16 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Standard Lidocaine

Active Comparator group

Description:

50mL 1% lidocaine in 450mL normal saline

Treatment:

Drug: Lidocaine

1/4 dose lidocaine

Experimental group

Description:

12.5mL 1% lidocaine in 487.5mL normal saline

Treatment:

Drug: Lidocaine