Prospective RCT Comparing Perioperative Pain

Study Overview
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Brief Summary
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This study is a non-blinded randomized controlled trial comparing the use of a preoperative mini block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.

Official Title
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Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial

Conditions
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Arthroplasty Shoulder

Intervention / Treatment
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* Drug: Saline
* Drug: Bupivacaine liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital. Exclusion Criteria: Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia Revision arthroplasty or arthroplasty for fracture Unable/unwilling to consent for enrollment Unable to complete postoperative pain survey Known adverse drug reaction or allergy to the medications used Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain) Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone) Patients under the age of 18 years Patients with history of hepatic disease Pregnant or breastfeeding women.

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative block plus saline<br>Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline | Drug: Saline<br>* A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative<br>|
| Active Comparator: Preoperative block plus Bupivacaine extended-release liposome<br>Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues) | Drug: Bupivacaine liposome<br>* an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine and morphine equivalent consumption |  | 24 hours post surgery |