Prospective Randomized Trial of Standard Versus pH-adjusted Radiocolloid for Patients Undergoing Sentinel Lymph Node Mapping and Biopsy for Breast Cancer PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial
Null hypothesis: There is no difference in overall pain intensity between standard and pH
adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for
breast cancer.
Objectives and scientific aims:
To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain
Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for
patients undergoing sentinel lymph node mapping and biopsy for breast cancer.
To assess objectively physician appraisal of patient pain during the radiocolloid injection
and compare physician interpreted pain score with patient reported pain score.
Define the success rate of intra-operative SLN identification for each study group.
Observational
Observational Model: Cohort, Time Perspective: Prospective
To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.
June 2009
No
Alexander Stojadinovic, M.D.
Principal Investigator
Walter Reed Army Medical Center
United States: Federal Government
WU#06-20027
NCT00940199
August 2006
June 2009
Name | Location |
---|---|
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |