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Clinical Trials/NCT02192411
NCT02192411
Unknown
Not Applicable

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

Midwest Vein Center1 site in 1 country70 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Lidocaine
Conditions
Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration
Sponsor
Midwest Vein Center
Enrollment
70
Locations
1
Primary Endpoint
Pain
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Midwest Vein Center
Responsible Party
Principal Investigator
Principal Investigator

Deborah Lindner, MD

Principle Investigator

Midwest Vein Center

Eligibility 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

Arms & Interventions

Standard Lidocaine

50mL 1% lidocaine in 450mL normal saline

Intervention: Lidocaine

1/4 dose lidocaine

12.5mL 1% lidocaine in 487.5mL normal saline

Intervention: Lidocaine

Outcomes

Primary Outcomes

Pain

Time Frame: 24 hours

Study Sites (1)

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