Percutaneously-Placed Continuous Flow Bupivacaine Pain Pumps to Decrease Post-operative Pain Following Mastectomy with Immediate Reconstruction
This study is being done to see if non-narcotic pain medicine delivered by a pain pump can help improve patientsâ?? pain following mastectomy and immediate tissue expander placement. The study compares patient-reported pain and use of pain medication (for example, narcotics) between patients treated with pain-relieving medicine (bupivacaine) or placebo (saline) administered via pain pump to the mastectomy site following immediate reconstruction with a tissue expander.
Eligible participants must â?¢Be Female aged 18-100 years old. â?¢Choose unilateral mastectomy followed by immediate tissue expander breast reconstruction. â?¢Have no inflammatory breast cancers. â?¢Be aware of the nature of her malignancy. â?¢Understand the study purpose, requirements, and risks. â?¢Be able and willing to give informed consent. Exclusion Criteria Participants with the following conditions will be ineligible: â?¢Any concurrent narcotic analgesic use (baseline narcotic use must be 0 to be eligible). â?¢Axillary lymph node dissection related to qualifying mastectomy.
This is a double-blind, randomized, controlled clinical trial, meaning neither the patient nor the physicians know what treatment the patient is receiving, and patients have a 50/50 (or the same) chance of receiving medicine or no medicine. Patients who have a mastectomy on one side and choose immediate breast reconstruction with a tissue expander are eligible. Once enrolled, participants will be asked to complete some questionnaires before being assigned to a treatment and having surgery. Information regarding participantsâ?? surgery and post-surgery pain, pain medication/narcotic use, and any problems will be recorded on Days 1, 2, and 3 after surgery. A clinic visit occurs on Day 7 when the pain pump is removed and additional data collected. A Pain Pump Questionnaire will be completed to record patientsâ?? opinions on the pain pump. Long-term quality-of-life/health outcomes will be measured on Day 90, Year 2, and Year 4 through participant-completed questionnaires.
03/10/2014 04:02 AM