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

NCT00925353 | Completed Phase 4 Results

• 1 other identifier: MSTMRI-002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adverse Effects

Keywords

lidocaine; pre-medication; mammography; pain; safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• EKG Changes

  Prior to gel application and 3 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.

  Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

• Frequencies of Moderate, Severe, or Life-threatening Side Effects

  Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Study Arms (1)

lidocaine gel

EXPERIMENTAL

Drug: 4% lidocaine gel

Interventions

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

Also known as: TOPICAINE

lidocaine gel

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• intact skin on breasts and chest wall

You may not qualify if:

• 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

Sponsors & Collaborators

• Mountain States Tumor and Medical Research Institute: lead

Study Sites (1)

St. Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Related 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.

  PMID: 22557743 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No placebo comparison group; limited sample size; healthy subjects; lack of variation in doses.

Results Point of Contact

• Title: Colleen K. Lambertz, MBA, MSN, FNP
• Organization: St. Luke's Mountain States Tumor and Medical Research Institute

lambertc@slhs.org

208 463 6018

Study Officials

• Colleen K Lambertz, MSN, FNP

  St. Luke's Mountain States Tumor Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 23, 2013
• Results First Posted: December 23, 2013

Record last verified: 2013-12

Locations

US (1)