Status:
COMPLETED
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Pain, Postoperative
Mammaplasty
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medic...
Detailed Description
Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivi...
Eligibility Criteria
Inclusion
- undergoing breast reconstruction with tissue expander
Exclusion
- history of adverse reaction to local anesthesia
- chronic liver disease
- history of chronic preoperative consumption of narcotics or opioids
- history of alcohol and/or illicit drug dependence
- undergoing combined procedures
- diagnosed with neuromuscular/neurosensory disorder
- positive pregnancy test
- previous breast conservation therapy (lumpectomy with radiation treatment
- previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
- axillary node dissection
- psychosis.
Key Trial Info
Start Date :
August 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04278846
Start Date
August 22 2014
End Date
May 15 2019
Last Update
July 1 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195