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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard Lidocaine

50mL 1% lidocaine in 450mL normal saline

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

1/4 dose lidocaine

12.5mL 1% lidocaine in 487.5mL normal saline

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

1/4 dose lidocaine

Interventions

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Lidocaine

1/4 dose lidocaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes