Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Detailed Description
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The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

Official Title
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Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty

Conditions
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Shoulder Arthroplasty

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine with adjuvants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing total shoulder arthroplasty (not a reverse) Age ≥ 18 years Ability to understand and the willingness to sign an IRB-approved informed consent document. ASA patient status I-III patients Weight Greater than or equal to 50 kg Exclusion Criteria: Contraindications to an interscalene block or phrenic blockade Infection at injection site Pre-existing neurological dysfunction affecting the operative extremity Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids BMI >40 Uncontrolled diabetes (A1c >8.0) Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.) Patients who are wards of the state History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine. Patients with moderate-severe hepatic or renal impairment

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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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: Liposomal Bupivacaine Interscalene brachial plexus (ISB)<br> | Drug: Liposomal bupivacaine<br>* Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)<br>|
| Active Comparator: Bupivacaine with adjuvants ISB<br> | Drug: Bupivacaine with adjuvants<br>* Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Scores for the First 48 Hours | Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome. | At 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Opioid Consumption for the First 48 Hours | Morphine milligram equivalents (MME) over a 48 hour period | up to 48 hours | 
| Satisfaction With Surgical Experience | Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction | at 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Replacement Surgery, Interscalene Nerve Block, Liposomal Bupivacaine, Shoulder pain, Regional anesthesia, Brachial plexus blockade