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Completed

NCT Number: NCT00925353

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

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).

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Key information

Conditions

Adverse Effects Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% lidocaine gel

Drug

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

Other names: TOPICAINE

Primary outcomes

  1. 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

    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 outcomes

  1. EKG Changes

    Time frame: 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.

  2. 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

    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.

  3. 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

    Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements

Sponsors and collaborators

Lead sponsor

Mountain States Tumor and Medical Research Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2009
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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