Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
Condition: Breast Cancer; Sentinel Lymph Node; Breast Neoplasms; Breast Cancer Female
MeSH terms: Breast Neoplasms
Intervention: Lidocaine patch; Buzzy(R); Ice pack
Intervention description: Lidocaine is a local anesthetic.; Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.; Ice cools the skin and can provide some numbing for pain.
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Masking: Single (Outcomes Assessor)
Masking description: Data will be analyzed with intervention arms masked.
Enrollment: 167.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sentinel Lymph Node Biopsy; Sentinel Lymph Node Mapping; Radioactive Tracer Injection; Nuclear Medicine; Radiocolloid Injection

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.
    

Eligibility criteria:

        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