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

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ClinicalTrials.gov Identifier: NCT00925353
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : December 23, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
Mountain States Tumor and Medical Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adverse Effects
Intervention Drug: 4% lidocaine gel
Enrollment 13
Recruitment Details Recruitment fliers were posted at St. Luke's health System's oncology, screening mammography, internal medicine, and family health clinics, in-patient hospitals, and Boise State University.
Pre-assignment Details 56 potential subjects responded to the fliers during the enrollment period. 31 did not meet study criteria. 13 enrolled. 3 did not meet the preliminary EKG or laboratory criteria and were withdrawn prior to gel application. 10 subjects completed the trial.
Arm/Group Title Lidocaine Gel
Hide Arm/Group Description 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Period Title: Overall Study
Started 13
Completed 10
Not Completed 3
Reason Not Completed
Failed preliminary EKG or lab criteria.             3
Arm/Group Title Lidocaine Gel
Hide Arm/Group Description 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  84.6%
>=65 years
2
  15.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
53.9  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
13
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
Hide Description 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.
Time Frame Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.
Arm/Group Title Lidocaine Gel Group
Hide Arm/Group Description:
Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. 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.
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Plasma concentration
160
Median (Full Range)
Unit of Measure: nanograms/mililiter
lidocaine
NA [1] 
(NA to 310)
MEGX
NA [1] 
(NA to NA)
[1]
Measured values were below the level of detection = 200 ng/ml
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidocaine Gel Group
Comments Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method non-compartmental pharmacokinetic
Comments The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.
Method of Estimation Estimation Parameter Actual lab results shown
Estimated Value 1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title EKG Changes
Hide Description The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.
Time Frame Prior to gel application and 3 hours after
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.
Hide Description 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.
Time Frame Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Frequencies of Moderate, Severe, or Life-threatening Side Effects
Hide Description Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
Time Frame Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Gel
Hide Arm/Group Description 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
All-Cause Mortality
Lidocaine Gel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine Gel
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Gel
Affected / at Risk (%) # Events
Total   7/10 (70.00%)    
Skin and subcutaneous tissue disorders   
Skin erythema   7/10 (70.00%)  7
Indicates events were collected by systematic assessment
No placebo comparison group; limited sample size; healthy subjects; lack of variation in doses.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Colleen K. Lambertz, MBA, MSN, FNP
Organization: St. Luke's Mountain States Tumor and Medical Research Institute
Phone: 208 463 6018
Responsible Party: Mountain States Tumor and Medical Research Institute
ClinicalTrials.gov Identifier: NCT00925353     History of Changes
Other Study ID Numbers: MSTMRI-002
First Submitted: June 18, 2009
First Posted: June 22, 2009
Results First Submitted: April 26, 2012
Results First Posted: December 23, 2013
Last Update Posted: December 23, 2013