Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Official Title
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Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery

Conditions
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Shoulder Pain, Rotator Cuff Tear

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine 0.25%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity. Exclusion Criteria: Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Ages Eligible for Study
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Minimum Age: 17 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine 0.25%<br>20 cc of bupivacaine 0.25% | Drug: Liposomal bupivacaine<br>* liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)<br>* Other names: Exparel;|
| Experimental: Liposomal bupivacaine<br>liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) | Drug: Bupivacaine 0.25%<br>* 20 cc of bupivacaine 0.25%<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block. | Post op Day 1, post op Day 2, post op day 3, post op 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Analgesia | The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain. | Post op Day 1, post op Day 2, post op day 3, post op 1 week | 
| Sensory and Motor Block | Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function. | at 20 min and at 1 hour | 
| Time to First Pain Medicine |  | 72 hours | 
| Time to Discharge Home | data not collected | 72 hours | 
| Incidence of Postoperative Nausea and Vomiting |  | 72 hours | 
| Sleep Quality | scale of 0-10, 0=horrible, up all night; 10=perfect sleep | Post op Day 1, post op Day 2, post op day 3, post op 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exparel, Liposomal Bupivacaine, Arthroscopic Shoulder Surgery