Liposomal Bupivacaine in Implant Based Breast Reconstruction

Objectives:

1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.

2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and
opioid related adverse events.

3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.

4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with
postoperative pain control.

5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

The objective of this project is to evaluate the role of liposomal bupivacaine in
postoperative pain control following tissue expander and implant based breast
reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of
action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This
agent has been demonstrated to be safe, well tolerated, and effective in a number of
different clinical applications. However, its role has yet to be evaluated in the context of
breast reconstruction.

Thus, the authors propose the first, randomized, controlled clinical trial of liposomal
bupivacaine for postoperative pain management following tissue expander and implant based
breast reconstruction. Patients will be stratified into two study groups. Patients in the
Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine
and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket.
This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will
be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg
delivered to perform a field block of each breast pocket. This is the experimental
intervention. Postoperatively, the investigators will assess pain levels, opioid
consumption, opioid related adverse events, length of stay, and satisfaction.

The findings from this study will allow the authors to better elucidate the role of
liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may
allow the authors to identify the ideal pain regimen for these patients. This holds
important implications, with the potential to reduce postoperative pain, opioid consumption,
opioid related adverse events, length of stay, and patient satisfaction.

Inclusion Criteria:

- Women undergoing immediate unilateral or bilateral tissue-expander breast
reconstruction following skin-sparing or nipple-sparing mastectomy

Exclusion Criteria:

- Women who are unable to give informed consent to participate in this study

- Women with a documented history of hypersensitivity reactions to local-anesthetic
agents

- Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic
migraine headaches, or psychiatric disorders other than depression or anxiety

- Women who are currently pregnant

- Women undergoing tissue expander based breast reconstruction with a muscle flap in
combination with a tissue expander

- Women with impaired hepatic function