Breast Cancer, Sentinel Lymph Node, Breast Neoplasms, Breast Cancer Female
Conditions
Keywords
Sentinel Lymph Node Biopsy, Sentinel Lymph Node Mapping, Radioactive Tracer Injection, Nuclear Medicine, Radiocolloid Injection
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.
Interventions
DRUGLidocaine patch
Lidocaine is a local anesthetic.
DEVICEBuzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
OTHERIce pack
Ice cools the skin and can provide some numbing for pain.
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Data will be analyzed with intervention arms masked.
Intervention model description
There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants from the UW Hospital and Clinics were enrolled from April 2021 to January 2022.
Participants by arm
| Arm | Count |
|---|---|
| Ice Pack Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) | 44 |
| Buzzy(R) A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. | 39 |
| Lidocaine Patch A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. | 44 |
| Lidocaine Patch and 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. | 40 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
| Overall Study | Subject withdrawn after enrollment | 0 | 1 | 0 | 1 |
| Overall Study | Surgery Re-scheduled, missed by study team | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Buzzy(R) | Lidocaine Patch | Ice Pack | Lidocaine Patch and Buzzy(R) | Total |
|---|---|---|---|---|---|
| Age, Customized 30-39 years | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Age, Customized 40-49 years | 7 Participants | 7 Participants | 6 Participants | 7 Participants | 27 Participants |
| Age, Customized 50-59 years | 14 Participants | 11 Participants | 6 Participants | 10 Participants | 41 Participants |
| Age, Customized 60-69 years | 10 Participants | 14 Participants | 16 Participants | 11 Participants | 51 Participants |
| Age, Customized 70-79 years | 4 Participants | 9 Participants | 14 Participants | 10 Participants | 37 Participants |
| Age, Customized 80-89 years | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 43 Participants | 41 Participants | 40 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 37 Participants | 44 Participants | 42 Participants | 37 Participants | 160 Participants |
| Region of Enrollment United States | 39 participants | 44 participants | 44 participants | 40 participants | 167 participants |
| Sex: Female, Male Female | 39 Participants | 44 Participants | 44 Participants | 40 Participants | 167 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 39 | 0 / 44 | 0 / 40 |
| other Total, other adverse events | 0 / 44 | 0 / 39 | 0 / 44 | 0 / 40 |
| serious Total, serious adverse events | 0 / 44 | 0 / 39 | 0 / 44 | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Median Post-Procedural Pain Score | 2 score on a scale |
| Buzzy(R) | Median Post-Procedural Pain Score | 2 score on a scale |
| Lidocaine Patch | Median Post-Procedural Pain Score | 4 score on a scale |
| Lidocaine Patch and Buzzy(R) | Median Post-Procedural Pain Score | 4 score on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ice Pack | Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious | 33 Participants |
| Buzzy(R) | Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious | 24 Participants |
| Lidocaine Patch | Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious | 32 Participants |
| Lidocaine Patch and Buzzy(R) | Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious | 25 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ice Pack | Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 42 Participants |
| Buzzy(R) | Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 37 Participants |
| Lidocaine Patch | Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 42 Participants |
| Lidocaine Patch and Buzzy(R) | Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 37 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ice Pack | Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 42 Participants |
| Buzzy(R) | Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 37 Participants |
| Lidocaine Patch | Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 42 Participants |
| Lidocaine Patch and Buzzy(R) | Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 37 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ice Pack | Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 33 Participants |
| Buzzy(R) | Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 33 Participants |
| Lidocaine Patch | Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 36 Participants |
| Lidocaine Patch and Buzzy(R) | Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied | 36 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Provider Perceived Ease of Administration | 7 score on a scale |
| Buzzy(R) | Provider Perceived Ease of Administration | 6 score on a scale |
| Lidocaine Patch | Provider Perceived Ease of Administration | 7 score on a scale |
| Lidocaine Patch and Buzzy(R) | Provider Perceived Ease of Administration | 6 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Provider Perceived Participant Pain | 3 score on a scale |
| Buzzy(R) | Provider Perceived Participant Pain | 3 score on a scale |
| Lidocaine Patch | Provider Perceived Participant Pain | 4 score on a scale |
| Lidocaine Patch and Buzzy(R) | Provider Perceived Participant Pain | 3 score on a scale |
Secondary
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)
Population: 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'
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ice Pack | Provider Rank Ordering Ease of Use of Interventions | 1 - easiest to administer | 1 Participants |
| Ice Pack | Provider Rank Ordering Ease of Use of Interventions | 2 | 7 Participants |
| Ice Pack | Provider Rank Ordering Ease of Use of Interventions | 3 | 0 Participants |
| Ice Pack | Provider Rank Ordering Ease of Use of Interventions | 4 - hardest to administer | 0 Participants |
| Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 2 | 0 Participants |
| Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 3 | 8 Participants |
| Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 4 - hardest to administer | 0 Participants |
| Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 1 - easiest to administer | 0 Participants |
| Lidocaine Patch | Provider Rank Ordering Ease of Use of Interventions | 3 | 0 Participants |
| Lidocaine Patch | Provider Rank Ordering Ease of Use of Interventions | 2 | 1 Participants |
| Lidocaine Patch | Provider Rank Ordering Ease of Use of Interventions | 4 - hardest to administer | 0 Participants |
| Lidocaine Patch | Provider Rank Ordering Ease of Use of Interventions | 1 - easiest to administer | 7 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 4 - hardest to administer | 8 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 2 | 0 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 1 - easiest to administer | 0 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Ease of Use of Interventions | 3 | 0 Participants |
Secondary
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)
Population: There were 8 providers that were not consented to the study because the IRB considered the 'study team members'
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ice Pack | Provider Rank Ordering Perceived Efficacy of Interventions | 2 | 2 Participants |
| Ice Pack | Provider Rank Ordering Perceived Efficacy of Interventions | 3 | 2 Participants |
| Ice Pack | Provider Rank Ordering Perceived Efficacy of Interventions | 4 - worst pain control | 2 Participants |
| Ice Pack | Provider Rank Ordering Perceived Efficacy of Interventions | 1 - best pain control | 2 Participants |
| Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 3 | 1 Participants |
| Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 4 - worst pain control | 1 Participants |
| Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 1 - best pain control | 2 Participants |
| Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 2 | 4 Participants |
| Lidocaine Patch | Provider Rank Ordering Perceived Efficacy of Interventions | 4 - worst pain control | 5 Participants |
| Lidocaine Patch | Provider Rank Ordering Perceived Efficacy of Interventions | 3 | 1 Participants |
| Lidocaine Patch | Provider Rank Ordering Perceived Efficacy of Interventions | 1 - best pain control | 0 Participants |
| Lidocaine Patch | Provider Rank Ordering Perceived Efficacy of Interventions | 2 | 2 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 1 - best pain control | 4 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 3 | 4 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 2 | 0 Participants |
| Lidocaine Patch and Buzzy(R) | Provider Rank Ordering Perceived Efficacy of Interventions | 4 - worst pain control | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ice Pack | Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered Yes | 31 Participants |
| Buzzy(R) | Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered Yes | 31 Participants |
| Lidocaine Patch | Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered Yes | 35 Participants |
| Lidocaine Patch and Buzzy(R) | Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered Yes | 35 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Short Form McGill Affective Pain Score | 0 score on a scale |
| Buzzy(R) | Short Form McGill Affective Pain Score | 0 score on a scale |
| Lidocaine Patch | Short Form McGill Affective Pain Score | 0 score on a scale |
| Lidocaine Patch and Buzzy(R) | Short Form McGill Affective Pain Score | 0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Short Form McGill Combined Pain Score | 4 score on a scale |
| Buzzy(R) | Short Form McGill Combined Pain Score | 3 score on a scale |
| Lidocaine Patch | Short Form McGill Combined Pain Score | 6 score on a scale |
| Lidocaine Patch and Buzzy(R) | Short Form McGill Combined Pain Score | 3 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Short Form McGill Sensory Pain Score | 1 score on a scale |
| Buzzy(R) | Short Form McGill Sensory Pain Score | 1 score on a scale |
| Lidocaine Patch | Short Form McGill Sensory Pain Score | 2 score on a scale |
| Lidocaine Patch and Buzzy(R) | Short Form McGill Sensory Pain Score | 2 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Pack | Short Form McGill VAS Pain Score | 24 score on a scale |
| Buzzy(R) | Short Form McGill VAS Pain Score | 28 score on a scale |
| Lidocaine Patch | Short Form McGill VAS Pain Score | 27 score on a scale |
| Lidocaine Patch and Buzzy(R) | Short Form McGill VAS Pain Score | 33 score on a scale |