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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
167
Lidocaine is a local anesthetic.
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice cools the skin and can provide some numbing for pain.
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
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".
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Short Form McGill Sensory Pain Score
Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain
Time frame: 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
Time frame: 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"
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: Assessed after last participant off study (up to 12.5 months)
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