Breast Cancer Clinical Trial
Official title:
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Research study to determine if putting local anesthetic—or numbing medication—through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2016 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - undergoing unilateral or bilateral mastectomy - desiring analgesia with a paravertebral nerve block(s) - age 18 years or older - female Exclusion Criteria: - morbid obesity as defined by a body mass index > 40 - renal insufficiency - chronic opioid use - history of opioid abuse - any comorbidity which results in moderate or severe functional limitation - inability to communicate with the investigators or hospital staff - pregnancy - incarceration |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCSD Thornton Hospital | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Scores (NRS) | Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory | Day following Surgery | No |
Secondary | Pain scores | Measured on the NRS (defined above) during the first 4 postoperative days | First 4 postoperative days | No |
Secondary | Opioid Requirements | Both in and out of the hospital during the first 3 postoperative days | First 4 postoperative days | No |
Secondary | Opioid-related side effects | Both in and out of the hospital during the first 4 postoperative days | First 4 postoperative days | No |
Secondary | Sleep Disturbances | Due to breast pain during the first 4 postoperative days | First 4 postoperative days | No |
Secondary | Cancer Recurrence | Patients' records will be investigated for indications of cancer recurrence up to 3 years following catheter placement (including estrogen receptor status as + or -). Patients may be contacted by phone if records suggest that the patient has not returned to the original surgeon within the previous 12 months | One Year following Surgery | No |
Secondary | Pain and Physical Functioning | Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12 | Within first year of surgery | No |
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