CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
Lidocaine patch +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04822597
NCT04822597Phase 3Completed

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

University of Wisconsin, Madison·interventional·Posted Mar 30, 2021·Updated Aug 3, 2023

In Brief

A Phase 3 clinical trial evaluating Lidocaine patch, Buzzy(R), and 1 other intervention for Breast Cancer and 3 related conditions. Completed, enrolled 167 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 30, 2021
Enrollment StartApr 23, 2021
Primary CompletionMay 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.3 years ago

Interventions

Lidocaine patchdrug

Lidocaine is a local anesthetic.

Buzzy(R)device

Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Ice packother

Ice cools the skin and can provide some numbing for pain.