Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

University of Wisconsin (UW)

Status and phase: Completed; Phase 3

Conditions: Sentinel Lymph Node; Breast Cancer; Breast Cancer Female; Breast Neoplasms

Treatments: Other: Ice pack; Drug: Lidocaine patch; Device: Buzzy(R)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04822597

SMPH/SURGERY/SURG ONC (Other Identifier)

2021-0261

UW20164 (Other Identifier)

A539713 (Other Identifier)

2T32CA090217-16 (U.S. NIH Grant/Contract)

Protocol Version 3/2022 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 site

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

167 participants in 4 patient groups

Ice Pack

Active Comparator group

Description:

Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)

Treatment:

Other: Ice pack

Lidocaine Patch

Experimental group

Description:

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection

Treatment:

Drug: Lidocaine patch

Buzzy(R)

Experimental group

Description:

A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.

Treatment:

Device: Buzzy(R)

Other: Ice pack

Lidocaine Patch and Buzzy(R)

Experimental group

Description:

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.

Treatment:

Device: Buzzy(R)

Drug: Lidocaine patch

Other: Ice pack