Exparel in Minimally Invasive Cardiac Surgery

Title of Study: Evaluation of the Efficacy of EXPAREL Delivered Into the Thoracotomy and
Chest Tube Sites After Minimally Invasive Cardiac Surgery

Hypothesis: There is no difference in, the use of analgesics or the length of analgesia
using Exparel infiltration when compared to regular bupivacaine.

Objectives: The investigators are presently using Exparel in patients undergoing minimally
invasive cardiac surgery. The primary objective of this study is to assess the efficacy of
EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged
postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy
will be assessed by: the effectiveness of analgesia as measured by the subject's overall
postoperative pain scores and postsurgical analgesic use. The safety of EXPAREL will be
assessed by the occurrence of all postsurgical adverse events and serious adverse event
through Day 30.

Methodology: This is a prospective, open-label, non-randomized study evaluating the
effectiveness of analgesia when using 266 mg EXPAREL delivered into the thoracotomy and
chest tube sites by wide local infiltration. All patients in the study will undergo
minimally invasive cardiac surgery. The total dose of EXPAREL for the thoracotomy and chest
tube sites will be the same for up to 20 study subjects.: 266 mg of EXPAREL (13.3 mg/mL
bupivacaine base). EXPAREL will be administered to each site. This total dose of Exparel is
not to be exceeded in any subject. The thoracotomy and chest tube sites in this study will
be performed immediately following surgery. Fentanyl will be the only opioid permitted
intraoperatively. Post-operatively pain medications will be administered per standard of
care by the anesthesia care team as needed to control the patient's pain. Patients will have
access to a variety of rescue analgesics with appropriate routes of administration for
breakthrough pain (e.g. opioids, acetaminophen, ketorolac, other nonsteroidal
antiinflammatory drugs) in accordance with hospital standing orders for postsurgical pain
management.

Subject reported pain will be recorded before surgery and at 2, 4, 8, 12, 24, 48, 72, 96,
and 120 hours after the thoracotomy and chest tube site infiltration), and at a generally
standard scheduled post-hospital discharge visit approximately 10±5 days after surgery.
(Subjects discharged from the hospital will be contacted by telephone to record the
scheduled pain assessments). Physician/healthcare professional assessed pain will be
recorded when the patient is intubated and unable to communicate. Pain will also be assessed
at the time of hospital discharge and at the last assessment (10±5 days) subjects also will
be asked about their overall satisfaction with postsurgical analgesia Patients will also be
asked to report any possible adverse events experienced since hospital discharge. If after
Day 10±5 and through Day 30, the investigator is made aware of an adverse evevts that
occurred during this period of time, this should also be recorded on the case report form if
the investigator feels the event may be related to the study drug.

Inclusion Criteria:

- Patients aged 18-75 years inclusive and American Society of Anesthesiologists
physical status 2-4.

- Undergoing minimally invasive cardiac surgery.

- Subjects must be physically and mentally able to participate in the study and
complete all study assessments.

- Subjects must be able to give fully informed consent to participate in this study
after demonstrating a good understanding of the risks and benefits of the proposed
components of thoracotomy and chest tube sites infiltration.

Exclusion Criteria:

- History of hypersensitivity or idiosyncratic reactions to amide-type local
anesthetics

- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator,
might preclude the potential successful performance of a thoracotomy and chest tube
sites infiltration.

- Any subject who in the opinion of the Investigator, might be harmed or be a poor
candidate for participation in the study.

- Any subject, who in the opinion of the Investigator, is on chronic pain medicine,
including large doses of nonsteroidal antiinflammatory drugs.

- Subjects who have received any investigational drug within 30 days prior to study
drug administration, or planned administration of another investigational product or
procedure during their participation in this study.