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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mountain States Tumor and Medical Research Institute
• Treatments: Lidocaine

Criteria

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