Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Study Overview
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Brief Summary
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Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

Detailed Description
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This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group. 266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day. It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.

Official Title
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Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Liposome Bupivacaine
* Drug: Bupivacaine HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Status I-III Scheduled to undergo primary unilateral total knee arthroplasty Exclusion Criteria: Patients who are pregnant or nursing Alcohol or narcotic dependence within the last 2 years Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator BMI > 40kg/m2 Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine Allergies to amide-type local anesthetics Any disease condition or lab result that could complicate a patients postoperative recovery History of hypotension Abnormal liver, renal or cardiac function Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposome Bupivacaine,<br>Liposome Bupivacaine 266mg, Knee Infiltration | Drug: Liposome Bupivacaine<br>* Administered via local tissue infiltration around the knee joint<br>* Other names: Bupivacaine Liposome, Injectable Suspension;|
| Active Comparator: Bupivacaine HCl<br>Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) | Drug: Bupivacaine HCl<br>* Administered via CFNB<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity at Movement | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity at Rest | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | 24hrs | 
| Opioid Consumption |  | 24hrs | 
| Mean Plasma Bupivicaine Level |  | 72hrs | 
| Mean Plasma Bupivacaine Levels |  | 48hrs | 
| Mean Plasma Bupivacaine Level |  | 24hrs | 
| Mean Plasma Bupivacaine Level |  | 12hrs | 
| Mean Plasma Bupivacaine Level |  | 4hrs | 
| Mean Plasma Bupivacaine Level |  | 2hrs | 
| Mean Plasma Bupivacaine Level |  | Baseline |