Clinical trial NCT00925353: The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
Official title: The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects
Keywords: lidocaine
pre-medication
mammography
pain
safety
Lead sponsor: Mountain States Tumor and Medical Research Institute
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 13
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
timeFrame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after
Secondary outcomes:
measure: EKG Changes
timeFrame: Prior to gel application and 3 hours after
measure: Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.
timeFrame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
measure: Frequencies of Moderate, Severe, or Life-threatening Side Effects
timeFrame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Other outcomes:
Locations:
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute
state: Idaho
Study officials:
affiliation: St. Luke's Mountain States Tumor Institute
name: Colleen K Lambertz, MSN, FNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambertz CK, Johnson CJ, Montgomery PG, Maxwell JR, Fry SJ. Toxicity of topical lidocaine applied to the breasts to reduce discomfort during screening mammography. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):200-4. doi: 10.4103/0970-9185.94859.