Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      Despite a robust multimodal pain management regimen, patients undergoing total knee
      arthroplasty (TKA) continue to report low satisfaction with postoperative pain management.
      Patient satisfaction further declines with any adverse event such as a drug reaction to
      neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain
      management throughout the hospital experience is warranted to improve patient satisfaction
      and the possibility of related adverse events. The purpose of this study is to examine if
      there is a difference in post operative pain and morphine (MSO4) total consumption for
      hospitalized TKA patients without femoral nerve block receiving an intra-operative
      periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.
    

Detailed description: 
      The void in the literature is that while multimodal pain management reduces postoperative
      pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain
      control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15.
      Additionally, postoperative falls are greater with femoral nerve blocks16, and new
      neurological symptoms are associated with the block17. Bupivacaine liposome suspension
      periarticular injection has large scale national anecdotal support for TKA pain control with
      avoidance of regional block adversity. There is one recent randomized control trial in TKA
      patients favorably comparing periarticular injection with bupivacaine liposome suspension
      versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most
      robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or
      hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint
      arthroplasty, a more effective and better tolerated pain management solution is needed.

      Hypothesis Statement:

      Hospitalized TKA patients without a pre-operative femoral nerve block will experience
      improved postoperative pain control and less MSO4 equivalence consumption when receiving an
      injection of bupivacaine liposome suspension versus concentrated multi drug.
    

Intervention name(s): bupivacaine liposome suspension; concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
Intervention type(s): Drug; Drug
Intervention description(s): bupivacaine liposome suspension periarticular injection; Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
Other intervention name(s): Exparel; Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
Intervention MeSH terms: Epinephrine; Racepinephrine; Morphine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment