Exparel for Postoperative Pain Management in Shoulder Surgery

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CISB control for B	0.125% Bupivacaine	Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation
Liposomal Bupivacaine A	1.3% Liposomal Bupivacaine	One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
Liposomal Bupivacaine B	1.3% Liposomal Bupivacaine	One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation
CISB control for A	0.125% Bupivacaine	Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .

Primary Outcome Measures

Name	Time	Method
Quality of Analgesia	30 days	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

Secondary Outcome Measures

Name	Time	Method
Post Operative American Shoulder and Elbow Surgeons (ASES)	Preoperative, 6 weeks and last follow up	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.
Incidence of Nerve Injury	During hospital stay and at 2 weeks and 6 weeks post-operatively	Neuropraxia on the treatment side
Post Operative Opioid Consumption	During hospital stay up to 48 hours after surgery	Cumulative amount of opioids administered during the time frame
Subjective Shoulder Value (SSV)	Pre-operative, 6 weeks and last Follow up	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%