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

NCT02192411 | Unknown DMC

• 1 other identifier: JVDL070714
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lidocaine; tumescent; endovenous; laser; pain

Outcome Measures

Primary Outcomes (1)

• Pain

  24 hours

Study Arms (2)

Standard Lidocaine

ACTIVE COMPARATOR

50mL 1% lidocaine in 450mL normal saline

Drug: Lidocaine

1/4 dose lidocaine

EXPERIMENTAL

12.5mL 1% lidocaine in 487.5mL normal saline

Drug: Lidocaine

Interventions

Lidocaine DRUG

1/4 dose lidocaine

1/4 dose lidocaine; Standard Lidocaine

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Large Saphenous Vein treatment
• 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

Sponsors & Collaborators

• Midwest Vein Center: lead

Study Sites (1)

Midwest Vein Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Deborah S Lindner, MD

CONTACT

3127183051; deborahsuemd@gmail.com

Jelena Vasic

CONTACT

5203498998; jelena.vasic@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (1)