Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection

A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.

Lidocaine patch

Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Buzzy(R)

Ice cools the skin and can provide some numbing for pain.

Ice pack

Heather B Neuman, MD

The purpose of this study is to compare the effectiveness four different pain treatments for the injection of radioactive tracer that women with breast cancer receive for sentinel lymph node biopsies.

This study will include women who have been diagnosed with breast cancer and who will be undergoing sentinel lymph node biopsy with a standard injection of radioactive tracer before surgery.

A participant's active participation will take place on two separate occasions. In the first occasion, a participant will complete a brief pain assessment on the day of enrollment. The rest of a participant's active participation will take place on one day (the day of surgery) and last approximately 20 minutes, after which active participation will end.

Primary Objective: To test the effectiveness of four alternative approaches to topical anesthesia on pain associated with radiotracer injection for women diagnosed with breast cancer undergoing sentinel lymph node mapping.

Secondary Objectives:

1. To assess patient satisfaction with pain control modality for radiotracer injection.
2. To identify barriers to implementation of the different pain control interventions.

There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.

Data will be analyzed with intervention arms masked.

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping

Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".

Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain

Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain

Visual analog scale pain score out of 100 with zero being "no pain" and 100 being "worst possible pain"

Combination of outcomes 2-3. Additive total score between 0 and 45 with zero being "no pain" and 45 being "severe pain"

1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.

1-4 scale with 1 being "very anxious" and 4 being "not at all anxious", reported here are the number of participants rating anxiety at 2 or "moderate".

"Yes", "No", "Not sure" with option for free response

7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy". This is the provider's perception of the how easy the intervention was to administer.

11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".

End of study survey to compare providers' perceived usability of intervention. Rank ordering of interventions 1-4 with 1 being "easiest to administer" and 4 being "hardest to administer".

End of study survey to compare providers' perceived efficacy of intervention. Rank ordering of interventions 1-4 with 1 being "best pain control" and 4 being "least pain control".

National Cancer Institute (NCI)

University of Wisconsin, Madison

Ice Pack

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.

Lidocaine Patch

Lidocaine Patch and Buzzy(R)

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heather B Neuman, MD, MS, FACS

Median Post-Procedural Pain Score

Short Form McGill Sensory Pain Score

Short Form McGill Affective Pain Score

Short Form McGill VAS Pain Score

Short Form McGill Combined Pain Score

Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied

Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied

Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied

Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious

Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"

Provider Perceived Ease of Administration

Provider Perceived Participant Pain

There were 8 providers surveyed to rank the ease of use of the interventions, they were not consented as the IRB considered them 'study team members'

Provider Rank Ordering Ease of Use of Interventions

There were 8 providers that were not consented to the study because the IRB considered the 'study team members'

Provider Rank Ordering Perceived Efficacy of Interventions

Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)

Ice pack: Ice cools the skin and can provide some numbing for pain.

A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.

Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Ice pack: Ice cools the skin and can provide some numbing for pain.

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection

Lidocaine patch: Lidocaine is a local anesthetic.

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.

Lidocaine patch: Lidocaine is a local anesthetic.

Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Ice pack: Ice cools the skin and can provide some numbing for pain.

Spots Global Cancer Trial Database for radioactive tracer injection