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

Adverse Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925353
• Other study ID #: MSTMRI-002
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2009
• Last updated: December 20, 2013
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: December 2013
• Source: Mountain States Tumor and Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adverse Effects

Intervention

Drug:
• 4% lidocaine gel
1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water

Locations

Country	Name	City	State
United States	St. Luke's Mountain States Tumor Institute	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Mountain States Tumor and Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.	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.	Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after	Yes
Secondary	EKG Changes	The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.	Prior to gel application and 3 hours after	Yes
Secondary	Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.	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.	Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after	Yes
Secondary	Frequencies of Moderate, Severe, or Life-threatening Side Effects	Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements	Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after	Yes