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

NCT ID: NCT00925353

Last Updated: 2013-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Adverse Effects

Keywords

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lidocaine pre-medication mammography pain safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lidocaine gel

Group Type EXPERIMENTAL

4% lidocaine gel

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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TOPICAINE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mountain States Tumor and Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colleen K Lambertz, MSN, FNP

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Mountain States Tumor Institute

Locations

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St. Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22557743 (View on PubMed)

Other Identifiers

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MSTMRI-002

Identifier Type: -

Identifier Source: org_study_id