Exparel for Postoperative Pain Management in Shoulder Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Detailed Description
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liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.

Official Title
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A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation

Conditions
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Fracture of Shoulder and Upper Arm

Intervention / Treatment
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* Drug: 1.3% Liposomal Bupivacaine
* Drug: 0.125% Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing shoulder arthroplasty under general anesthesia Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3 Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines. Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond. Patients available for follow up routine post-operative clinic visits, per standard of care. Exclusion Criteria: Contraindications to regional anesthesia Significant peripheral neuropathy or neurological disorder affecting the upper extremity Contraindication to a component of multimodal analgesia Pregnancy Opioid tolerance Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

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 |
| --- | --- |
| Experimental: Liposomal Bupivacaine A<br>One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty | Drug: 1.3% Liposomal Bupivacaine<br>* local tissue infiltration of Liposomal Bupivacaine during surgery<br>* Other names: Exparel;|
| Active Comparator: CISB control for A<br>Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . | Drug: 0.125% Bupivacaine<br>* Continues nerve block with Bupivacaine during surgery and postoperatively<br>* Other names: Bupivacaine;|
| Experimental: Liposomal Bupivacaine B<br>One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation | Drug: 1.3% Liposomal Bupivacaine<br>* local tissue infiltration of Liposomal Bupivacaine during surgery<br>* Other names: Exparel;|
| Active Comparator: CISB control for B<br>Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation | Drug: 0.125% Bupivacaine<br>* Continues nerve block with Bupivacaine during surgery and postoperatively<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Analgesia | Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative American Shoulder and Elbow Surgeons (ASES) | American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome. | Preoperative, 6 weeks and last follow up | 
| Subjective Shoulder Value (SSV) | Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100% | Pre-operative, 6 weeks and last Follow up | 
| Incidence of Nerve Injury | Neuropraxia on the treatment side | During hospital stay and at 2 weeks and 6 weeks post-operatively | 
| Post Operative Opioid Consumption | Cumulative amount of opioids administered during the time frame | During hospital stay up to 48 hours after surgery |