Evaluation Exparel Delivered in Knee Replacement
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain control after knee replacement requires analgesia to both the top (anterior) and bottom
      (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion.
      The investigators want to to examine if giving Exparel into the posterior portion will give
      better pain relief.

      Hypothesis: There is no difference in, the use of analgesics or the length and quality of
      analgesia and no decrease in the time to be able to accomplish simple to complex knee
      movements using Exparel infiltration when compared to controls.
    

Detailed description: 
      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, post anesthesia care unit (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.
    

Intervention name(s): Exparel; Saline
Intervention type(s): Drug; Other
Intervention description(s): Exparel is infiltrated into posterior compartment for pain control; Saline is infiltrated into posterior compartment for control
Other intervention name(s): Bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment