Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Phase 3

Completed

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

Interventions: Drug: Lidocaine patch
Device: Buzzy(R)
Other: Ice pack

Registration Number: NCT04822597

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 167

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy(R)	Ice pack	A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Lidocaine Patch	Lidocaine patch	A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Lidocaine Patch and Buzzy(R)	Ice pack	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.
Ice Pack	Ice pack	Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Lidocaine Patch and Buzzy(R)	Lidocaine patch	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.
Buzzy(R)	Buzzy(R)	A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Lidocaine Patch and Buzzy(R)	Buzzy(R)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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