Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
NCT ID: NCT04822597
Last Updated: 2023-08-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
167 participants
INTERVENTIONAL
2021-04-23
2022-05-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of a Radiolucent Pad to Reduce Mammography Among African Americans
NCT00594282
Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
NCT02137252
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
NCT00068263
Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
NCT00602628
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
NCT06574022
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ice Pack
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Ice pack
Ice cools the skin and can provide some numbing for pain.
Lidocaine Patch
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Lidocaine patch
Lidocaine is a local anesthetic.
Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack
Ice cools the skin and can provide some numbing for pain.
Lidocaine Patch and Buzzy(R)
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
Lidocaine patch
Lidocaine is a local anesthetic.
Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack
Ice cools the skin and can provide some numbing for pain.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidocaine patch
Lidocaine is a local anesthetic.
Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack
Ice cools the skin and can provide some numbing for pain.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather B Neuman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin Madison School of Medicine and Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A539713
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/SURG ONC
Identifier Type: OTHER
Identifier Source: secondary_id
UW20164
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 3/2022
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.