Evaluation Exparel Delivered in Knee Replacement

Objectives:

1. Is to assess the efficacy of pain control of Exparel vs. controls when injected into
the posterior capsular space after total knee arthroplasty

2. Asses the opioid use after Exparel vs. controls

3. Asses the time to simple and complex knee movement and ambulation.

4. The safety of Exparel will be assessed by the occurrence of all postsurgical adverse
events and serious adverse events through Day 30.

Methods:

After institutional review board (IRB) approval, 20 subjects will be consented to
participate in the study. The study includes subjects undergoing total knee arthroplasty
either under general or spinal anesthesia. This study will include men and women (18 - 75
years) who have American Society of Anesthesiologist physical classification status 1 - 3
and underwent total knee arthroplasty.

Subjects will be divided into two groups, Group A (control) to receive 20ml of saline while
Group B (study) to receive 20ml of liposomal bupivacaine into the posterior capsular space
during total knee arthroplasty. Patients from both groups will receive a femoral nerve block
with catheter placement for continuous infusion of local anesthetic. All subjects will have
access to rescue analgesics after surgery. Multimodal analgesia will supplement pain as per
standard care by the anesthesia team. Tylenol Orally 1g three times daily (not to exceed 4g
in 24hrs), oxycontin 10mg orally, twice/day, Celebrex 200 mg orally once a day and Percocet
5/325 prn will serve as this multimodal approach. The time, day and number of requests for
break through (additional) analgesia will be noted by both anesthesia team and primary care
team. Pain scores will be assessed using a 0 - 10 numeric scale. Pain will be assessed for
the following intervals: hospital arrival, PACU arrival, 2, 4, 8, 12, 24, 48, 72, hours
later and after hospital discharge 10 +/- 5 days after the block. Pain inquiries will assess
both posterior and anterior aspects of the knee. Pain at rest and for simple leg movements
(knee extension, straight leg raise) to fully ambulatory will be noted. These assessments
will be made in conjunction with rehabilitation and physical therapy specialists.

Inclusion Criteria:

- Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical
status 1-3

- Patients undergoing knee replacement (total knee arthroplasty)

- 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 infiltration into the posterior capsule of the knee.

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 appropriate Exparel
infiltration into the posterior capsule of the knee.

- 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
(opioids), including large doses of non-steroidal anti-inflammatory drugs s.

- 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.

- History of pre-existing neurological disorders/neuropathy

- Morbid Obesity