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

Phase 4
35 Years
Not Enrolling
Adverse Effects

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma concentration of lidocaine and MEGX after one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.

Outcome Time Frame:

Prior to gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after

Safety Issue:


Principal Investigator

Colleen K Lambertz, MSN, FNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Luke's Mountain States Tumor Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

February 2010

Related Keywords:

  • Adverse Effects
  • lidocaine
  • pre-medication
  • mammography
  • pain
  • safety



St. Luke's Mountain States Tumor InstituteBoise, Idaho  83712