Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

Study Overview
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Brief Summary
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A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either: a local cocktail. a local cocktail plus Exparel. marcaine plus Exparel prior to wound closure following knee arthroplasty.

Detailed Description
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As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control. Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either: a local cocktail. a local cocktail plus Exparel. marcaine plus Exparel prior to wound closure following knee arthroplasty. METHODOLOGY Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.

Official Title
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A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

Conditions
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Total Knee Arthroplasty, Pain Management

Intervention / Treatment
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* Drug: Cocktail
* Drug: Exparel
* Drug: Marcaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained The subject underwent a primary total knee replacement under adductor canal block with general anesthesia Exclusion Criteria: The subject is a minor The subject is on chronic narcotics The subject has an indwelling pain pump The subject is having a knee revision surgery The subject is having a partial knee replacement The subject has a history of sepsis in a previously replaced joint The subject has back pain The subject has radicular pain The subject suffers from depression The subject has fibromyalgia The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized Group A [Cocktail Injection]<br>COCKTAIL INJECTION: Cocktail Injection Consists of: Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1 mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose | Drug: Cocktail<br>* Administered as a single dose injection.<br>* Other names: Nexiclon;|
| Experimental: Randomized Group B [Cocktail Injection Plus Exparel]<br>COCKTAIL INJECTION PLUS EXPAREL: Cocktail Injection Consists of: Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose | Drug: Cocktail<br>* Administered as a single dose injection.<br>* Other names: Nexiclon;Drug: Exparel<br>* Administered 20 minutes+ before additional medications.<br>* Other names: Bupivacaine Liposome;|
| Experimental: Randomized Group C [Marcaine Plus Exparel]<br>MARCAINE PLUS EXPAREL: Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose | Drug: Exparel<br>* Administered 20 minutes+ before additional medications.<br>* Other names: Bupivacaine Liposome;Drug: Marcaine<br>* Administered 20 minutes or more after Exparel is administered.<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively. |  | Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Knee Replacement, Exparel, Cocktail Injection, Pain Management