Liposomal Bupivacaine Versus Interscalene Nerve Block

Study Overview
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Brief Summary
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The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.

Official Title
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Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Exparel
* Procedure: Interscalene Nerve Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are older than 18 years patients undergoing reverse total shoulder arthroplasty Exclusion Criteria: pregnancy inability to provide informed consent deemed unreliable for follow-up survey completion individuals who do not speak English those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>Patients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline). | Drug: Exparel<br>* Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.<br>|
| Other: Interscalene Nerve Block<br>Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine. | Procedure: Interscalene Nerve Block<br>* Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse) | 72 hours post-operatively | 
| Visual Analog Scale Pain Scores | Post-operative level of pain measured from 0 (no pain) to 10 (worst pain) | 72 hours post-operatively | 
| Patient Satisfaction: Rating | Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied) | 72 hours post-operatively | 
| Relationship between catastrophizing, pain, and patient satisfaction | The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction. | Catastrophizing will be measured pre-operatively | 
| Relationship between resilience, pain, and patient satisfaction | The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction. | Resilience will be measured pre-operatively |