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

Study Overview
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Brief Summary
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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).

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

Conditions
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Adverse Effects

Intervention / Treatment
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* Drug: 4% lidocaine gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine gel<br> | Drug: 4% lidocaine gel<br>* 1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water<br>* Other names: TOPICAINE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. | 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 | 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, pre-medication, mammography, pain, safety