Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buzzy(R) | Device | — | UNRESOLVED |
| Ice pack | Other | — | UNRESOLVED |
| Lidocaine patch | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Ice Pack
- description
- Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
- interventionNames
- Other: Ice pack
- type
- EXPERIMENTAL
- label
- Lidocaine Patch
- description
- A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
- interventionNames
- Drug: Lidocaine patch
- type
- EXPERIMENTAL
- label
- Buzzy(R)
- description
- A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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 Criteria:
* 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 siteReferences
Publications (0)
Data not yet available