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

This study has been completed.
Sponsor:
Information provided by:
Mountain States Tumor and Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00925353
First received: June 18, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  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:

MedlinePlus related topics: Mammography
U.S. FDA Resources

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

Primary Outcome Measures:
  • Plasma concentration of lidocaine and MEGX after one-time application 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. [ 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 ]

Secondary Outcome Measures:
  • EKG changes [ Time Frame: Prior to gel application and 3 hours after ] [ Designated as safety issue: Yes ]
  • Adverse 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 ]

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
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

No publications provided

Responsible Party: Colleen K. Lambertz, FNP Principal Investigator, St. Luke's Mountain States Tumor Institute
ClinicalTrials.gov Identifier: NCT00925353     History of Changes
Other Study ID Numbers: MSTMRI-002
Study First Received: June 18, 2009
Last Updated: September 23, 2010
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

ClinicalTrials.gov processed this record on June 17, 2013