The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
- Registration Number
- NCT00925353
- Lead Sponsor
- Mountain States Tumor and Medical Research Institute
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 13
- 35 years and older
- intact skin on breasts and chest wall
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lidocaine gel 4% lidocaine gel -
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after 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.
- Secondary Outcome Measures
Name Time Method EKG Changes Prior to gel application and 3 hours after The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.
Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time. Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 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 was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.
Frequencies of Moderate, Severe, or Life-threatening Side Effects Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
Trial Locations
- Locations (1)
St. Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
St. Luke's Mountain States Tumor Institute🇺🇸Boise, Idaho, United States