Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Study Overview
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Brief Summary
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This is a randomized prospective study of 60 patients undergoing total knee arthroplasty evaluating the clinical outcomes of liposomal bupivacaine periarticular injections (PAI) when compared to single shot adductor canal block using bupivacaine HCl.

Detailed Description
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Total knee arthroplasty(TKA) is an effective solution for end stage arthritis of the knee; however, post-surgical pain can be difficult to manage and the optimal peri-operative pain management strategy has not been established. This study serves to evaluate the clinical outcomes of liposomal bupivacaine PAI when compared to single shot adductor canal block using bupivacaine HCl in patients undergoing a TKA. The investigators hypothesized that peri-articular injection with liposomal bupivacaine would not be inferior to an adductor canal block using bupivacaine HCl. A total of 60 patients were recruited. Thirty patients were randomized to receive intraoperative liposomal bupivacaine periarticular injection, and another thirty patients randomized to receive a pre-operative adductor canal block using bupivacaine. Both groups otherwise received standard pain management strategies peri-operatively. The primary outcome of interest was post-operative pain, which was measured using the Visual Analog Scale (VAS). Secondary measures included changes in patient function which was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, post-operative ambulation distance, and hospital length of stay.

Official Title
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Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study

Conditions
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Total Knee Arthroplasty, Post-operative Pain Control

Intervention / Treatment
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* Procedure: Liposomal Bupivacaine Peri-articular Injection
* Procedure: Adductor canal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral primary total knee arthroplasty for end stage osteoarthritis or rheumatoid arthritis. All adults > 18 years of age. Exclusion Criteria: Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.) Adults undergoing bilateral primary total knee arthroplasties. Women who are pregnant. Women who are breastfeeding. Inability to receive successful spinal anesthesia. Allergy to amide anesthetics. Inability to receive IV tranexamic acid. Patients who are unable to speak English. Patients who are less than 66kg. Patients who are opioid dependent. We define opioid dependency as patients who are on a long-acting narcotic or patients who are taking more than six tablets of hydrocodone 5mg or equivalent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Adductor Canal Block Group<br>Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery. | Procedure: Adductor canal block<br>* Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl<br>|
| Experimental: Liposomal Bupivacaine Group<br>Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery. | Procedure: Liposomal Bupivacaine Peri-articular Injection<br>* A 20mL solution of 266mg of liposomal bupivacaine (Exparel) was mixed with 40mL of normal saline, which was then infiltrated consistently in the posterior capsule, medial and lateral side of the arthrotomy, patella tendon, quadriceps tendon, quadriceps musculature, and subcutaneous soft tissue.<br>* Other names: Exparel peri-articular injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain) | VAS pain score on post-operative day #1 | 
| Visual Analog Scale (VAS) | Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain) | VAS pain score on post-operative day #2 | 
| Visual Analog Scale (VAS) | Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain) | VAS pain score on post-operative day #4 | 
| Visual Analog Scale (VAS) | Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain) | VAS pain score on post-operative day #7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Reported WOMAC Score ranges between 0 (worst) to 100 (best) | Outcome measure will be assessed up to 8 weeks | 
| Knee range of motion | Knee flexion and extension will be recorded during follow up visits | Outcome measure will be assessed up to 8 weeks | 
| Ambulation distance after surgery | Distance walked in feet will be assessed and recorded by physical therapist | Recorded on post-operative day #1 | 
| Hospital length of stay | Measured by number of nights patient stayed in hospital after surgery | Measure outcome will be assess through study completion, on average of 1 year |