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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine gel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EKG Changes | The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen K Lambertz, MSN, FNP | St. Luke's Mountain States Tumor Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22557743 | Result | 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. |
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56 potential subjects responded to the fliers during the enrollment period. 31 did not meet study criteria. 13 enrolled. 3 did not meet the preliminary EKG or laboratory criteria and were withdrawn prior to gel application. 10 subjects completed the trial.
Recruitment fliers were posted at St. Luke's health System's oncology, screening mammography, internal medicine, and family health clinics, in-patient hospitals, and Boise State University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Gel | 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Gel | 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL. | Posted | Median | Full Range | nanograms/mililiter | Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after | plasma concentration | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Gel | 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
No placebo comparison group; limited sample size; healthy subjects; lack of variation in doses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen K. Lambertz, MBA, MSN, FNP | St. Luke's Mountain States Tumor and Medical Research Institute | 208 463 6018 | lambertc@slhs.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 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 | Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements | Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Lidocaine Gel Group |
Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. 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. |
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| Secondary | EKG Changes | The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests. | Not Posted | Mean | Standard Error | msec | Prior to gel application and 3 hours after |
| Secondary | Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time. | 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. | Not Posted | Mean | Standard Error | bpm, rpm, mm Hg | Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after |
| Secondary | Frequencies of Moderate, Severe, or Life-threatening Side Effects | Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements | Not Posted | Number | Percentage of participants | Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after |
| 0 |
| 10 |
| 7 |
| 10 |
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