Phase 3 N=167 Randomized Single-blind Supportive Care

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Breast Cancer · Sentinel Lymph Node · Breast Neoplasms · Breast Cancer Female

Bottom Line

View on ClinicalTrials.gov: NCT04822597 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Median Post-Procedural Pain Score — 2; 2; 4; 4 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lidocaine patch (Drug); Buzzy(R) (Device); Ice pack (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Wisconsin, Madison
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Post-Procedural Pain Score	2; 2; 4; 4	—
SECONDARY Short Form McGill Sensory Pain Score	1; 1; 2; 2	—
SECONDARY Short Form McGill Affective Pain Score	0; 0; 0; 0	—
SECONDARY Short Form McGill VAS Pain Score	24; 28; 27; 33	—
SECONDARY Short Form McGill Combined Pain Score	4; 3; 6; 3	—
SECONDARY Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied	42; 37; 42; 37	—
SECONDARY Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied	42; 37; 42; 37	—
SECONDARY Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied	33; 33; 36; 36	—
SECONDARY Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious	33; 24; 32; 25	—
SECONDARY Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"	31; 31; 35; 35	—
SECONDARY Provider Perceived Ease of Administration	7; 6; 7; 6	—
SECONDARY Provider Perceived Participant Pain	3; 3; 4; 3	—
SECONDARY Provider Rank Ordering Ease of Use of Interventions	1; 0; 7; 0; 7; 0	—
SECONDARY Provider Rank Ordering Perceived Efficacy of Interventions	2; 2; 0; 4; 2; 4	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04822597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.