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| ID | Type | Description | Link |
|---|---|---|---|
| A539713 | Other Identifier | UW Madison | |
| SMPH/SURGERY/SURG ONC | Other Identifier | UW Madison | |
| UW20164 | Other Identifier | UWCCC | |
| Protocol Version 3/2022 | Other Identifier | UW Madison | |
| 2T32CA090217-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice Pack | Active Comparator | Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) |
|
| Lidocaine Patch | Experimental | A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection |
|
| Buzzy(R) | Experimental | A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. |
|
| Lidocaine Patch and Buzzy(R) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch | Drug | Lidocaine is a local anesthetic. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
males
pregnancy
local anesthetic allergy or active use of the following medications:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Heather B Neuman, MD | University of Wisconsin Madison School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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Participants from the UW Hospital and Clinics were enrolled from April 2021 to January 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ice Pack | 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. |
| FG001 | Buzzy(R) | 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. |
| FG002 | 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: Lidocaine is a local anesthetic. |
| FG003 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ice Pack | Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) |
| BG001 | Buzzy(R) | A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ice Pack | Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather B Neuman, MD, MS, FACS | University of Wisconsin School of Medicine and Public Health | (608) 263-7064 | neuman@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 | Feb 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2021 | May 23, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
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Data will be analyzed with intervention arms masked.
| Buzzy(R) | Device | Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations. |
|
|
| Ice pack | Other | Ice cools the skin and can provide some numbing for pain. |
|
|
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) |
| Physician Decision |
|
| Subject withdrawn after enrollment |
|
| Surgery Re-scheduled, missed by study team |
|
| BG002 | Lidocaine Patch | A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lidocaine Patch |
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. |
| OG003 | 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. |
|
|
| Secondary | Short Form McGill Sensory Pain Score | Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| Secondary | Short Form McGill Affective Pain Score | Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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" | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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" | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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. | Posted | Count of Participants | Participants | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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. | Posted | Count of Participants | Participants | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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. | Posted | Count of Participants | Participants | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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". | Posted | Count of Participants | Participants | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| Secondary | Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes" | "Yes", "No", "Not sure" with option for free response | Posted | Count of Participants | Participants | Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection |
|
|
|
| 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". | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery, assessed within 30 minutes of radioactive tracer injection |
|
|
|
| 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". | 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' | Posted | Count of Participants | Participants | Assessed after last participant off study (up to 12.5 months) |
|
|
|
| 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". | There were 8 providers that were not consented to the study because the IRB considered the 'study team members' | Posted | Count of Participants | Participants | Assessed after last participant off study (up to 12.5 months) |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Buzzy(R) | A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Lidocaine Patch | A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG003 | 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| 2 |
|
| 3 |
|
| 4 - hardest to administer |
|
| 2 |
|
| 3 |
|
| 4 - worst pain control |
|