Status:
COMPLETED
Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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....
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 sentin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT04822597
Start Date
April 23 2021
End Date
May 9 2022
Last Update
August 3 2023
Active Locations (1)
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1
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792