Overview

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
Female
Summary
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Treatments:
BB 1101
Bupivacaine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Epinephrine
Epinephryl borate
Racepinephrine
Criteria
Inclusion Criteria:

- Patients who undergo mastectomy surgery with immediate reconstruction involving
insertion of a tissue expander performed by the principal investigator beginning from
the time of study approval until study enrollment is complete.

Exclusion Criteria:

- Patients under the age of 18, or over the age of 79

- Allergy to local anesthetics or corticosteroids

- Patients with history of chronic pain or with chronic use of opioid analgesics

- Patients with history of lung disease or prior anterior thoracotomy or median
sternotomy