Exparel for Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings METHODS Sample size: Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled. Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes Treatment arms: Control: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out. Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.

Detailed Description
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The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 hours after TSA compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings METHODS Sample size: Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled. Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes Treatment arms: Control: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out. Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.

Official Title
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Randomized Clinical Trial of Exparel vs Pain Pump for Post-operative Pain Control After Total Shoulder Arthroplasty

Conditions
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Total Shoulder Arthroplasty

Intervention / Treatment
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* Drug: Exparel
* Drug: Pain Pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Exparel<br>Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine | Drug: Exparel<br>* Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine<br>|
| Active Comparator: Pain pump<br>Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. | Drug: Pain Pump<br>* Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score in the 24 hours after surgery | Worst pain score (0 [none] to 10 [worst possible]) in the 24 hours after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score in the 48 hours after surgery | Worst pain score (0 [none] to 10 [worst possible]) in the 48 hours after surgery | 48 hours | 
| Pain score in the 72 hours after surgery | Worst pain score (0 [none] to 10 [worst possible]) in the 72 hours after surgery | 72 hours | 
| Cumulative Morphine Milligram Equivalents at 24 hours | Cumulative Morphine Milligram Equivalents consumed at 24 hours | 24 hours | 
| Cumulative Morphine Milligram Equivalents at 48 hours | Cumulative Morphine Milligram Equivalents consumed at 48 hours | 48 hours | 
| Cumulative Morphine Milligram Equivalents at 72 hours | Cumulative Morphine Milligram Equivalents consumed at 72 hours | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Shoulder Arthroplasty, Post-operative Pain, Pain pump, Liposomal Bupivacaine