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

Mountain States Tumor and Medical Research Institute

Status and phase

Completed

Phase 4

Conditions

Adverse Effects

Treatments

Drug: 4% lidocaine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT00925353

MSTMRI-002

Details and patient eligibility

About

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).

Enrollment

13 patients

Sex

Female

Ages

35+ years old

Volunteers

No Healthy Volunteers

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