PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 06/30/2009 |
| First Submitted: | 07/13/2009 |
| Estimated Enrollment Submitted: | 07/13/2009 |
| First Posted: | 07/14/2009 |
| Last Update Submitted: | 07/13/2009 |
| Last Update Posted: | 07/14/2009 |
| Actual Study Start Date: | 07/31/2006 |
| Estimated Primary Completion Date: | 05/31/2009 |
| Estimated Study Completion Date: | 05/31/2009 |
Condition or disease
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Standard of Care I:Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline) | |
| 1 mCi in sodium bicarbonate II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate) | |
| 1 mCi in 1% Lidocaine III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine) | |
| 1 mCi in sodium bicarbonate + 1% Lidocaine IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion criteria: 1. Female military healthcare beneficiaries should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy. 2. Written informed consent must be obtained from each patient prior to entering the study. 3. Female military healthcare beneficiaries with early breast cancer scheduled to undergo sentinel lymph node mapping and biopsy at WRAMC Exclusion criteria: 1. Female military healthcare beneficiaries with chronic pain syndrome (e.g. fibromyalgia) undergoing active narcotic-based treatment. 2. Female military healthcare beneficiaries participating in other clinical trials the requirements of which may preclude complete involvement in this study. 3. Female military healthcare beneficiaries with significant allergy to local anesthetics. 4. Female military healthcare beneficiaries presenting with large (>4cm), clinically node positive, painful, locally advanced breast cancer. |
Outcome
Primary Outcome Measures
1. 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]
Secondary Outcome Measures
1. To assess objectively physician appraisal of patient pain during the radiocolloid injection and compare physician interpreted pain score with patient reported pain score [June 2009]
