The Use Of Liposomal Bupivacaine For Pain Control

Eligible subjects will be identified prior to surgery. On the day of surgery, each patient
will be randomized to be in either Local infiltration of bupivacaine OR liposomal
bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to
the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine
with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal
bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25%
bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the
mastectomy and prior to the insertion of the tissue expander implant. After this
intraoperative injection, patients will not receive any more doses of local anesthetics.

Inclusion Criteria:

- All patients who receive a bilateral mastectomy with immediate 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.