Efficacy of Liposomal Bupivacaine for Prolonged Postop Analgesia for Breast Reconstruction With Tissue Expander

• Status: Completed
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: Female

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 medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• undergoing breast reconstruction with tissue expander

Exclusion Criteria:

• 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.