Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

Not Applicable

Completed

Interventions: Drug: bupivacaine liposome suspension
Drug: concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease)
Severe knee deformity
Post-traumatic and inflammatory arthritis
BMI above 40
Patients unable to receive multimodal pain remitting agents
Active knee sepsis
Remote sites of active infection
Diabetes with A1C > 7
ASA class > lll
Cardiac disease failing medical clearance
Severe liver disease
PAD with AAI < 0.75
Seizure disorder
Allergic to any pain remitting agent
Alcohol abuse
Smoking abuse

Arm && Interventions

Group	Intervention	Description
bupivacaine liposome suspension	bupivacaine liposome suspension	bupivacaine liposome suspension periarticular injection
concentrated multi drug injection	concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL	concentrated multi drug periarticular injection

Primary Outcome Measures