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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mountain States Tumor and Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00925353
First received: June 18, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Adverse Effects
Drug: 4% lidocaine gel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Resource links provided by NLM:


Further study details as provided by Mountain States Tumor and Medical Research Institute:

Primary Outcome Measures:
  • Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. [ Time Frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after ] [ Designated as safety issue: Yes ]
    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:
  • EKG Changes [ Time Frame: Prior to gel application and 3 hours after ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after ] [ Designated as safety issue: Yes ]
    Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements


Enrollment: 13
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine gel 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
Other Name: TOPICAINE

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925353

Locations
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Sponsors and Collaborators
Mountain States Tumor and Medical Research Institute
Investigators
Principal Investigator: Colleen K Lambertz, MSN, FNP St. Luke's Mountain States Tumor Institute
  More Information

Publications:
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;28:200-4.

Responsible Party: Mountain States Tumor and Medical Research Institute
ClinicalTrials.gov Identifier: NCT00925353     History of Changes
Other Study ID Numbers: MSTMRI-002
Study First Received: June 18, 2009
Results First Received: April 26, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mountain States Tumor and Medical Research Institute:
lidocaine
pre-medication
mammography
pain
safety

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014