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

Not Applicable

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

• Registration Number: NCT02192411
• Lead Sponsor: Midwest Vein Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Lidocaine	Lidocaine	50mL 1% lidocaine in 450mL normal saline
1/4 dose lidocaine	Lidocaine	12.5mL 1% lidocaine in 487.5mL normal saline

Primary Outcome Measures

Name	Time	Method
Pain	24 hours

Trial Locations

Locations (1)

Midwest Vein Center; 🇺🇸 Chicago, Illinois, United States