ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02192411
Recruitment Status : Unknown
Verified July 2014 by Deborah Lindner, MD, Midwest Vein Center.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Deborah Lindner, MD, 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.

Condition or disease Intervention/treatment Phase
Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration Drug: Lidocaine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Lidocaine
50mL 1% lidocaine in 450mL normal saline
Drug: Lidocaine
1/4 dose lidocaine

Experimental: 1/4 dose lidocaine
12.5mL 1% lidocaine in 487.5mL normal saline
Drug: Lidocaine
1/4 dose lidocaine




Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192411


Contacts
Contact: Deborah S Lindner, MD 3127183051 deborahsuemd@gmail.com
Contact: Jelena Vasic 5203498998 jelena.vasic@northwestern.edu

Locations
United States, Illinois
Midwest Vein Center Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Deborah S Lindner, MD         
Sponsors and Collaborators
Midwest Vein Center

Responsible Party: Deborah Lindner, MD, Principle Investigator, Midwest Vein Center
ClinicalTrials.gov Identifier: NCT02192411     History of Changes
Other Study ID Numbers: JVDL070714
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Deborah Lindner, MD, Midwest Vein Center:
lidocaine
tumescent
endovenous
laser
pain

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action