Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain
Status:
Withdrawn
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and
pain medication/narcotic use between patients randomized to treatment (bupivacaine) or
placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen
to have a mastectomy on one side immediately followed with tissue expander placement breast
reconstruction.
Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled
percutaneously-placed pain pumps; neither the participants nor the study staff will know
participants' treatment. Data on patient-perceived pain and pain medication use will be
collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and
at Years 2 and 4 by phone.
The investigators hypothesize that patients randomized to the treatment (bupivacaine) group
will have significantly lower pain scores and use less pain medicine than patients who
receive placebo during the first 90 days following their surgery. The Year 2 and Year 4
follow-ups are included as tertiary endpoints to capture differences in chronic pain, and
patients will be asked to complete the same questionnaires as at the Day 90 follow up.