Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to determine quantitative and qualitative differences in
      post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who
      receive administration of a newly approved, long acting local anesthetic branded as ExparelTM
      (bupivacaine liposome injectable suspension) introduced by one of two different
      administration methods.

      Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly
      into the joint capsule at the conclusion of the surgery, effectively bathing the joint in
      anesthetic solution.

      Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local
      infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9)
      standard sites at the conclusion of the surgery.
    

Detailed description: 
      This study is being done to determine if a difference exists between two methods of
      intraoperative (during surgery) administration of a long-acting local anesthetic (pain
      relief).

      Local pain relief medications are accepted as standard of care as a part of a comprehensive
      plan for pain relief following a total knee replacement (arthroplasty) (TKA). We expect that
      the addition of ExparelTM to the usual post-surgery pain control medicines and procedures
      will result in less need for additional pain medication. It is possible that local injection
      into the tissue around the total knee replacement joint (periarticular tissues) may provide
      more effective pain relief than injection directly into the joint (intracapsular) itself, or
      vice versa. It is also possible that pain relief with either method is approximately
      equivalent. On the day of surgery, each patient will undergo total knee arthroplasty and
      cared for utilizing the standard protocol for all patients that undergo total knee
      arthroplasty at Broward Health Medical Center.

      Patients in Group 1 will receive the same amount of ExparelTM injected intracapsularly. Those
      in is Group 2 will receive a standardized medication regimen including ExparelTM by local
      infiltration into the periarticular tissues at the conclusion of their TKA procedure. Study
      participants will undergo injection in this manner until the conclusion of the study.

      All subjects will be provided the same methods of postoperative pain control following their
      TKA surgery as those patients not enrolled in the study.
    

Intervention name(s): Intracapsular Injection; Periarticular Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication.; The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint
Other intervention name(s): Intracapsular injection of bupivacaine liposome (ExparelTM); Periarticular injection of bupivacaine liposome (ExparelTM)
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee arthroplasty; Exparel; Bupivacaine liposome; Total knee replacement; Pain control