Exparel for Postoperative Pain Management in Shoulder Surgery

Wayne State University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fracture of Shoulder and Upper Arm

Interventions

1.3% Liposomal BupivacaineDRUG

local tissue infiltration of Liposomal Bupivacaine during surgery

0.125% BupivacaineDRUG

Continues nerve block with Bupivacaine during surgery and postoperatively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wayne State University Physician Group

Dearborn, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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%

Time frame: Pre-operative, 6 weeks and last Follow up

Incidence of Nerve Injury

Neuropraxia on the treatment side

Time frame: 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

Time frame: During hospital stay up to 48 hours after surgery

Data from ClinicalTrials.gov

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