Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Breast Cancer, Sentinel Lymph Node, Breast Neoplasms, Breast Cancer Female

Intervention / Treatment
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* Drug: Lidocaine patch
* Device: Buzzy(R)
* Other: Ice pack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than or equal to 18 years of age biopsy proven breast cancer standard radiotracer injection (intradermal injection in the upper outer quadrant of the involved breast) radiotracer injection occurs on the same day as sentinel lymph node surgery Exclusion Criteria: males pregnancy local anesthetic allergy or active use of the following medications: Abametapir (risk X) Conivaptan (risk X) Fusidic Acid (risk X) Idelalisib (risk X) Mifepristone (risk D) Stiripentol (risk D) Amiodarone (risk C) Dofetilide (risk C) Dronedarone (risk C) Ibutilide (risk C) Sotalol (risk C) Vernakalant (risk C) Non-English speaking/reading Unable to provide informed consent Unable to participate with surveys Undergoing radiotracer injection the day prior to surgery or intra-operatively at the time of initial surgical scheduling If patients are initially scheduled for same-day preoperative injection, complete all enrollment procedures (including randomization), and surgery is re-scheduled for a day prior to surgery or for intra-operative injection, they will be excluded if: randomized to a lidocaine patch arm (Arms C or D) re-scheduled for an intra-operative injection • Planned non-standard radiotracer injection site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ice Pack<br>Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) | Other: Ice pack<br>* Ice cools the skin and can provide some numbing for pain.<br>* Other names: coolant;|
| Experimental: Lidocaine Patch<br>A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection | Drug: Lidocaine patch<br>* Lidocaine is a local anesthetic.<br>* Other names: topical lidocaine 4%;|
| Experimental: Buzzy(R)<br>A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. | Device: Buzzy(R)<br>* Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.<br>* Other names: therapeutic vibrator;Other: Ice pack<br>* Ice cools the skin and can provide some numbing for pain.<br>* Other names: coolant;|
| Experimental: Lidocaine Patch and Buzzy(R)<br>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. | Drug: Lidocaine patch<br>* Lidocaine is a local anesthetic.<br>* Other names: topical lidocaine 4%;Device: Buzzy(R)<br>* Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.<br>* Other names: therapeutic vibrator;Other: Ice pack<br>* Ice cools the skin and can provide some numbing for pain.<br>* Other names: coolant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Post-Procedural Pain Score | Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being no pain and 10 being worst pain. | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form McGill Sensory Pain Score | Sensory pain score out of 33 with 0 being no pain and 33 being severe sensory pain | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Short Form McGill Affective Pain Score | Affective pain score out of 12 with 0 being no pain and 12 being severe affective pain | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Short Form McGill VAS Pain Score | Visual analog scale pain score out of 100 with zero being no pain and 100 being worst possible pain | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Short Form McGill Combined Pain Score | Combination of outcomes 2-3. Additive total score between 0 and 45 with zero being no pain and 45 being severe pain | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 1-6 scale with 1 being very satisfied and 6 being very dissatisfied. Reported are the number of participants satisfied or very satisfied. | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 1-6 scale with 1 being very satisfied and 6 being very dissatisfied. Reported are the number of participants satisfied or very satisfied. | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 1-6 scale with 1 being very satisfied and 6 being very dissatisfied. Reported are the number of participants satisfied or very satisfied. | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious | 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. | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered Yes | Yes, No, Not sure with option for free response | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection | 
| Provider Perceived Ease of Administration | 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. | Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection | 
| Provider Perceived Participant Pain | 11 point numeric rating scale for perceived pain of others. 0 being no pain and 7-10 being severe pain. | Day of surgery, assessed within 30 minutes of radioactive tracer injection | 
| Provider Rank Ordering Ease of Use of Interventions | 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. | Assessed after last participant off study (up to 12.5 months) | 
| Provider Rank Ordering Perceived Efficacy of Interventions | 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. | Assessed after last participant off study (up to 12.5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Sentinel Lymph Node Mapping, Radioactive Tracer Injection, Nuclear Medicine, Radiocolloid Injection