Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Official Title
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Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial

Conditions
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Analgesia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age or older Undergoing total shoulder arthroplasty Willing and able to sign consent form to participate in study Exclusion Criteria: < 18 years of age Unwilling or unable to sign consent form to participate in study Allergy to local anesthetic Medical contraindication to interscalene nerve block Chronic opioid use

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL. | Drug: Liposomal bupivacaine<br>* Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.<br>* Other names: Exparel;Drug: Bupivacaine<br>* Active comparator as standard of care.<br>|
| Active Comparator: Non-liposomal Bupivacaine<br>Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine | Drug: Bupivacaine<br>* Active comparator as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Morphine equivalents used during first 72 hours after surgery | 72 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale Reported Pain Scores | Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain | 72 hours postoperative | 
| Nerve Block Related Adverse Events | Any adverse event determined to be caused as a result of having a nerve block to include but not limited to toxicity, allergic reaction, nerve injury. | 72 hours postoperative | 
| Patients with Additional, Unanticipated Pain Related Medical Encounters | Any unanticipated, unplanned, pain related phone calls to surgeon or anesthesiologist for rescue pain treatment, pain related emergency department visits or primary care physician visits for pain treatment | 72 hours postoperative | 
| Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale | Patient reported satisfaction with their postoperative pain control using the numeric rating scale from 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied | 72 hours postoperative |