Liposomal Bupivacaine vs Dexamethasone ISB

Study Overview
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Brief Summary
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In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Official Title
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Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial

Conditions
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Shoulder Pain

Intervention / Treatment
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* Drug: Exparel 133 MG Per 10 ML Injection
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Age 18 years or older Scheduled for elective outpatient arthroscopic shoulder surgery Exclusion Criteria: History of allergy to local anesthetic, or one of the study medications Pre-existing neurological deficits Psychiatric or cognitive disorders that prohibit patients from following study protocol History of drug or alcohol abuse Chronic opioid use (longer than 3 months) Chronic pain syndromes Infection at the site of injection Patients with severe pulmonary disease Herniated cervical disc, cervical myelopathy Contraindication for general anesthesia and/or interscalene nerve block Pregnancy Open shoulder arthrotomies. Non English speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine & standard bupivacaine<br> | Drug: Exparel 133 MG Per 10 ML Injection<br>* 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)<br>* Other names: Liposomal Bupivacaine;|
| Active Comparator: Standard bupivacaine & dexamethasone<br> | Drug: Dexamethasone<br>* 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome. | First 72 hours pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) Pain at Rest | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | 
| Numerical Rating Scale (NRS) Pain With Movement | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | 
| Opioid Consumption | Opioid consumption, measured in oral morphine equivalents | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | 
| Patient Satisfaction With Pain Management: Scale | Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | 
| Brief Pain Inventory Short-form | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | 
| Duration of Analgesic Block | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked When did your pain relief from the block completely wear off? This indicates the block duration. | 24, 48, 72, 96 (if needed) hours postoperatively | 
| Sensory Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | 24, 48, 72, 96 (if needed) hours postoperatively | 
| Motor Block Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | 24, 48, 72, 96 (if needed) hours postoperatively | 
| Time to Readiness for Discharge | Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System. | Postanesthesia care unit (0-6 hours postoperative) | 
| Postanesthesia Care Unit Length of Stay | Total length of PACU stay as defined by time of PACU admission to PACU discharge. | Postanesthesia care unit (0-6 hours postoperative) |