Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.

Official Title
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Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial

Conditions
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Arthroplasty Complications, Adductor Canal Block, Peripheral Nerve Block, Opioid Use

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Procedure: Drug: SoC Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is scheduled for elective unilateral primary TKA The subject is ≥ 18 years The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural) The patient consents for an adductor canal block Willing and able to sign an informed consent. Exclusion Criteria: Patients unwilling or unable to consent to participate in the study. Prisoners. Pregnancy. Reported to have mental illness or belonging to a vulnerable population. Subject is < 18 years of age. Patients receiving general anesthesia for the total knee arthroplasty. Subject has impaired decision-making capacity per discretion of the Investigator. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate. Significant pre-existing neuropathy on the operative limb. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I & II, among others). Subject has sustained a significant trauma to the operative knee. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months). Known hypersensitivity and/or allergies to local anesthetics. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy. Patients with impaired renal function such that they cannot receive IV Toradol.

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine Standard of Care Group<br>Participants undergoing elective Total Knee Arthoplasty (TKA) surgery that are randomized to the control group will undergo an ultrasound-guided Adductor Canal Block (ACB) with standard of care (SoC) Ropivacaine post TKA surgery. | Procedure: Drug: SoC Ropivacaine<br>* 0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.<br>|
| Experimental: Liposomal Bupivacaine Intervention Group<br>Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery. | Drug: Liposomal bupivacaine<br>* 266 mg or 20 ml Liposomal Bupivacaine injectable solution<br>* Other names: Exparel;Procedure: Drug: SoC Ropivacaine<br>* 0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Ambulated with physical therapist | Average daily distance ambulated using the 6 minute walk test | Up to 5 days | 
| Length of hospitalization | Number of days of hospitalization after elective admission for TKA surgery | Up to 5 days | 
| Incidence of events of PONV | Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization | Up to 5 days | 
| Number of participants requiring narcotic prescriptions | The number of participants that require further narcotic prescriptions will be reported | 2 weeks | 
| Incidence of urinary retention from narcotic use | Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization. | 2 Weeks | 
| Post-Operative Pain Score | Post-Operative Pain will be measured via a self-reported Visual Analog Scale (VAS) score. The VAS Pain score ranges from 1-10 with 1 being free of pain and 10 being the most pain. | Up to 5 days | 
| Patient Satisfaction as per the Knee Society Score | The Knee society score has a total score ranging from 100-0. Scores between 100 and 85 points are considered excellent results, scores between 84 and 70 points are considered good results. Scores between 69 and 60 points are considered fair, and scores less than 60 are considered poor results | Up to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty