NCT04822597

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-23
• Primary completion: 2022-05-09
• Completion: 2022-05-09
• First posted: 2021-03-30
• Last updated: 2023-08-03
• Results posted: 2023-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study