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Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

NCT04822597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2023-08-03

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Heather B Neuman, MD · University of Wisconsin Madison School of Medicine and Public Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2022-05-09
Completion
2022-05-09
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822597 on ClinicalTrials.gov