The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Study Overview
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Brief Summary
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Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Detailed Description
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Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

Official Title
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The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Drug: EXPAREL 1.3 % in 20 ML Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-72 years of age Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators Exclusion Criteria: Planned concomitant glenoid labral repair Previous open shoulder surgery Neurological deficit or other disability involving the surgical extremity Anyone with a documented allergy to bupivicaine Subjects that are not mentally competent to give consent Pregnant women Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EXPAREL 1.3 % in 20 ML Injection<br>EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors: size of surgical site volume required to cover the area individual patient factors that may impact the safety of an amide local anesthetic maximum doe of 266 mg (20 mL) | Drug: EXPAREL 1.3 % in 20 ML Injection<br>* EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.<br>* Other names: bupivacaine liposome injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Log of Pain Score | Daily reported patient numeric pain rating | 2 weeks | 
| Daily Log of Narcotic Medication Usage | Number of narcotic medication consumed | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | Pain score measured utilizing patient questionnaire answers | 2 week follow-up visit | 
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | Function score measured utilizing patient questionnaire answers | 2 week follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Rotator cuff