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NCT Number: NCT04822597

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

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.

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Key information

Conditions

Breast Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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:

  • To assess patient satisfaction with pain control modality for radiotracer injection.
  • To identify barriers to implementation of the different pain control interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine patch

Drug

Lidocaine is a local anesthetic.

Other names: topical lidocaine 4%

Buzzy(R)

Device

Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Other names: vibrating distraction device, therapeutic vibrator

ice pack

Other

Ice cools the skin and can provide some numbing for pain.

Other names: ice, coolant

Primary outcomes

  1. Median Post-Procedural Pain Score

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".

Secondary outcomes

  1. Short Form McGill Sensory Pain Score

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain

  2. Short Form McGill Affective Pain Score

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain

  3. Short Form McGill VAS Pain Score

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    Visual analog scale pain score out of 100 with zero being "no pain" and 100 being "worst possible pain"

  4. Short Form McGill Combined Pain Score

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    Combination of outcomes 2-3. Additive total score between 0 and 45 with zero being "no pain" and 45 being "severe pain"

  5. Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.

  6. Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.

  7. Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.

  8. Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    1-4 scale with 1 being "very anxious" and 4 being "not at all anxious", reported here are the number of participants rating anxiety at 2 or "moderate".

  9. Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"

    Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

    "Yes", "No", "Not sure" with option for free response

  10. Provider Perceived Ease of Administration

    Time frame: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection

    7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy". This is the provider's perception of the how easy the intervention was to administer.

  11. Provider Perceived Participant Pain

    Time frame: Day of surgery, assessed within 30 minutes of radioactive tracer injection

    11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".

  12. Provider Rank Ordering Ease of Use of Interventions

    Time frame: Assessed after last participant off study (up to 12.5 months)

    End of study survey to compare providers' perceived usability of intervention. Rank ordering of interventions 1-4 with 1 being "easiest to administer" and 4 being "hardest to administer".

  13. Provider Rank Ordering Perceived Efficacy of Interventions

    Time frame: Assessed after last participant off study (up to 12.5 months)

    End of study survey to compare providers' perceived efficacy of intervention. Rank ordering of interventions 1-4 with 1 being "best pain control" and 4 being "least pain control".

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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