Status:
WITHDRAWN
Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain
Lead Sponsor:
Johns Hopkins University
Conditions:
Pain
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief 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) del...
Detailed Description
Double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivere...
Eligibility Criteria
Inclusion
- Be Female aged 18-100 years.
- Choose unilateral mastectomy followed by immediate tissue expander breast reconstruction.
- Have no inflammatory breast cancers.
- Be aware of the nature of her malignancy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
Exclusion
- Any concurrent narcotic analgesic use (baseline narcotic use must be 0 to be eligible).
- Axillary lymph node dissection related to qualifying mastectomy.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01494259
Start Date
January 1 2016
End Date
September 1 2017
Last Update
October 14 2015
Active Locations (1)
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1
Dept. of Plastic and Reconstructive Surgery, Johns Hopkins
Baltimore, Maryland, United States, 21287