Overview

The Use Of Liposomal Bupivacaine For Pain Control

Status:
Completed
Trial end date:
2020-01-29
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University Health Sciences
Treatments:
Bupivacaine
Criteria
Inclusion Criteria:

- All patients who receive a bilateral mastectomy with immediate sub-pectoral implant
based breast reconstruction

- Age ≥ 18 years

- Ability to understand and the willingness to sign an (Institutional Review Board)
IRB-approved informed consent document.

- Patients who receive tissue expander placement or direct permanent implant placement
will be included in the study.

Exclusion Criteria:

- Patients who receive an autologous tissue reconstruction.

- Patients who receive a unilateral reconstruction.

- Patients who are expected to undergo axillary lymph node dissection

- Patients who have undergone breast irradiation

- Patients who abuse narcotics or have chronic pain (using greater than 40 mg
equivalents of oxycodone per day)

- Patients who are wards of the state

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to bupivacaine or liposomal bupivacaine.

- Pregnant women are excluded from this study because pregnancy precluded immediate
breast reconstruction in our patient population.

- Patients who weigh less than 50 kg, as there can be dose related toxicities of the
bupivacaine dosing used n this study.

- Patients with moderate-severe hepatic or renal impairment because of the increased
risk of toxicity.

- Patients receiving bilateral mastectomy with immediate pre-pectoral implant based
reconstruction