Exparel for Postoperative Pain Management in Shoulder Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture of Shoulder and Upper Arm
• Intervention / Treatment: Drug: 1.3% Liposomal Bupivacaine; Drug: 0.125% Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Wayne State University Physician Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Bupivacaine A; One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty	Drug: 1.3% Liposomal Bupivacaine; local tissue infiltration of Liposomal Bupivacaine during surgery; Other Names: Exparel
Active Comparator: CISB control for A; Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .	Drug: 0.125% Bupivacaine; Continues nerve block with Bupivacaine during surgery and postoperatively; Other Names: Bupivacaine
Experimental: Liposomal Bupivacaine B; One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation	Drug: 1.3% Liposomal Bupivacaine; local tissue infiltration of Liposomal Bupivacaine during surgery; Other Names: Exparel
Active Comparator: CISB control for B; Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation	Drug: 0.125% Bupivacaine; Continues nerve block with Bupivacaine during surgery and postoperatively; Other Names: Bupivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimated): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Pain, Postoperative; Shoulder Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2014-193