Clinical trial NCT04822597: Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
Official title: Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Sentinel Lymph Node
Breast Neoplasms
Breast Cancer Female
Keywords: Sentinel Lymph Node Biopsy
Sentinel Lymph Node Mapping
Radioactive Tracer Injection
Nuclear Medicine
Radiocolloid Injection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-30
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Median Post-Procedural Pain Score
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Secondary outcomes:
measure: Short Form McGill Sensory Pain Score
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Short Form McGill Affective Pain Score
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Short Form McGill VAS Pain Score
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Short Form McGill Combined Pain Score
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
timeFrame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
measure: Provider Perceived Ease of Administration
timeFrame: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection
measure: Provider Perceived Participant Pain
timeFrame: Day of surgery, assessed within 30 minutes of radioactive tracer injection
measure: Provider Rank Ordering Ease of Use of Interventions
timeFrame: Assessed after last participant off study (up to 12.5 months)
measure: Provider Rank Ordering Perceived Efficacy of Interventions
timeFrame: Assessed after last participant off study (up to 12.5 months)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Madison School of Medicine and Public Health
name: Heather B Neuman, MD
role: PRINCIPAL_INVESTIGATOR
References: