Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: 0.5% Bupivacaine HCL; Drug: Liposomal Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing total shoulder arthroplasty;
• Patients who consent to be randomized.

Exclusion Criteria:

• Patients younger than 18 and older than 75;
• Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
• Patients who are allergic to oxycodone;
• Patients who are unable to speak English;
• Patients with diagnosed or self---reported cognitive dysfunction;
• Patients with a history of neurologic disorder that can interfere with pain sensation;
• Patients with a history of drug or recorded alcohol abuse;
• Patients who are unable to understand or follow instructions;
• Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
• Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
• Patients with BMI over 40;
• Any patient that the investigators feel cannot comply with all study related procedures;
• NYU Langone Health students, residents, faculty or staff members

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 mL 0.5% Bupivacaine HCL	Drug: 0.5% Bupivacaine HCL; 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Experimental: Interscalene nerve block with Liposomal + Bupivacaine 0.5%; Administered in an Interscalene block for TSA	Drug: Liposomal Bupivacaine; Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Utilization	Measure in morphine milligram equivalents [MME]	24-72 hour, Post-Operative Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Utilization	Measure in morphine milligram equivalents [MME]	Day 4-7, Post-Operative Period
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale	PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5.; = No pain; = Mild; = Moderate; = Severe; = Very Severe	Day 1-7, Post-Operative Period
T-Scores, PROMIS Pain Intensity Scale	PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.	Day 1-7, Post-Operative Period

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Uchenna Umeh, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 19, 2021
• Study Completion (Actual): January 19, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 18-01183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available to achieve aims in the approved proposal.
• IPD Sharing Time Frame: Immediately following publication. No end date

IPD Sharing Access Criteria

Requests should be directed to uchenna.umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Access will be given to researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes