The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

December 20, 2013 updated by: Mountain States Tumor and Medical Research Institute
The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Mountain States Tumor Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 35 years and older
  • intact skin on breasts and chest wall

Exclusion Criteria:

  • sensitivity or allergy to lidocaine
  • liver or kidney dysfunction
  • pregnant
  • breast feeding
  • currently smoke or chew tobacco
  • used lidocaine products within 48 hours of baseline lab, EKG, or gel application
  • exhibit neurological or cardiac signs or symptoms prior to gel application
  • are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
  • history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
  • heart rate below 60 or above 100 beats per minute
  • systolic blood pressure below 95 or above 180 mm Hg
  • PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
  • have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
  • have had cancer, surgery, trauma, or myocardial infarction in the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lidocaine gel
Drug: 4% lidocaine gel
1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water
Other Names:
  • TOPICAINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
Time Frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after
Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.
Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EKG Changes
Time Frame: Prior to gel application and 3 hours after
The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.
Prior to gel application and 3 hours after
Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.
Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.
Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Frequencies of Moderate, Severe, or Life-threatening Side Effects
Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mountain States Tumor and Medical Research Institute

Investigators

  • Principal Investigator: Colleen K Lambertz, MSN, FNP, St. Luke's Mountain States Tumor Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (ESTIMATE)

June 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSTMRI-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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