Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.

Official Title
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Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: liposomal bupivacaine
* Drug: bupivacaine HCl
* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female between the ages of 18-65 Patients willing and able to sign the informed consent Patients able to comply with follow-up requirements including self-evaluations Patients requiring a primary total knee replacement Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis Exclusion Criteria: Revision total knee arthroplasty Bilateral total knee arthroplasty Patients with inflammatory arthritis Patients with a body mass index (BMI) > 40 Allergy to ropivacaine, bupivacaine, or other local anesthetic agents Current use of opioid drugs Patients with a history of total or unicompartmental reconstruction of the affected joint Patients that have had a high tibial osteotomy or femoral osteotomy Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels Patients with a systemic or metabolic disorder leading to progressive bone deterioration Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis Patients with knee fusion to the affected joint Patients with an active or suspected latent infection in or about the knee joint Patients that are prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Liposomal bupivacaine<br>Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants | Drug: liposomal bupivacaine<br> <br> * Other names: Exparel;Drug: bupivacaine HCl<br> <br> * Other names: Marcaine;Drug: Saline<br> <br> |
| Active Comparator: Adductor canal and tibial nerve block<br>Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour | Drug: bupivacaine HCl<br> <br> * Other names: Marcaine;Drug: Ropivacaine<br> <br> * Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS, in days) |  | Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days | 
| Time to ambulation (in hours) |  | 2-6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as assessed by visual analog scale (VAS) on postoperative day 0 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 6 hours | 
| Pain as assessed by visual analog scale (VAS) on postoperative day 1 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 24 hours | 
| Pain as assessed by visual analog scale (VAS) on postoperative day 2 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 48 hours | 
| Pain as assessed by visual analog scale (VAS) on postoperative day 3 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 72 hours | 
| Pain as assessed by visual analog scale (VAS) on postoperative day 4 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 96 hours | 
| Pain as assessed by visual analog scale (VAS) on postoperative day 5 | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 | 120 hours | 
| Opioid consumption in oral morphine equivalents (OMEs, in milligrams) |  | Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days. | 
| Postoperative complications and adverse events |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Osteoarthritis, Arthritis, Joint Diseases, Ropivacaine, Anesthetics, Local, Anesthetics