Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822597
• Other study ID #: 2021-0261
• Secondary ID: A539713SMPH/SURG
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Drug:
• Lidocaine patch
Lidocaine is a local anesthetic.

Device:
• Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Other:
• Ice pack
Ice cools the skin and can provide some numbing for pain.

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	Day of surgery (last of two study visits), assessed within 3 hours of 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	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	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"	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"	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.	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.	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.	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".	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	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.	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".	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".	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".	Assessed after last participant off study (up to 12.5 months)