Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms; Sentinel Lymph Node; Breast Cancer Female
• Intervention / Treatment: Other: Ice pack; Drug: Lidocaine patch; Device: Buzzy(R)

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.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heather B Neuman, MD, University of Wisconsin Madison School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Sentinel Lymph Node Biopsy; Nuclear Medicine; Sentinel Lymph Node Mapping; Radioactive Tracer Injection; Radiocolloid Injection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2021-0261; SMPH/SURGERY/SURG ONC (Other Identifier: UW Madison); A539713 (Other Identifier: UW Madison); UW20164 (Other Identifier: UWCCC); Protocol Version 3/2022 (Other Identifier: UW Madison); 2T32CA090217-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No