Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Median Post-Procedural Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data will be analyzed with intervention arms masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ice Pack
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
干预措施: Ice pack (Other)
Lidocaine Patch
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
干预措施: Lidocaine patch (Drug)
Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
干预措施: Buzzy(R) (Device)
Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
干预措施: Ice pack (Other)
Lidocaine Patch and Buzzy(R)
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.
干预措施: Lidocaine patch (Drug)
Lidocaine Patch and Buzzy(R)
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.
干预措施: Buzzy(R) (Device)
Lidocaine Patch and Buzzy(R)
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.
干预措施: Ice pack (Other)
结局指标
主要结局
Median Post-Procedural Pain Score
时间窗: 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".
次要结局
- Provider Perceived Ease of Administration(Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection)
- Provider Perceived Participant Pain(Day of surgery, assessed within 30 minutes of radioactive tracer injection)
- Short Form McGill Sensory Pain Score(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Short Form McGill Affective Pain Score(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Short Form McGill VAS Pain Score(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Short Form McGill Combined Pain Score(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious(Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection)
- Provider Rank Ordering Ease of Use of Interventions(Assessed after last participant off study (up to 12.5 months))
- Provider Rank Ordering Perceived Efficacy of Interventions(Assessed after last participant off study (up to 12.5 months))