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)

NCT03913091 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-01183
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain

Keywords

Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)

Outcome Measures

Primary Outcomes (1)

• Opioid Utilization

  Measure in morphine milligram equivalents \[MME\]

  24-72 hour, Post-Operative Period

Secondary Outcomes (3)

• Opioid Utilization

  Day 4-7, Post-Operative Period

• Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale

  Day 1-7, Post-Operative Period

• T-Scores, PROMIS Pain Intensity Scale

  Day 1-7, Post-Operative Period

Study Arms (2)

20 mL 0.5% Bupivacaine HCL

EXPERIMENTAL

Drug: 0.5% Bupivacaine HCL

Interscalene nerve block with Liposomal + Bupivacaine 0.5%

EXPERIMENTAL

Administered in an Interscalene block for TSA

Drug: Liposomal Bupivacaine

Interventions

Liposomal Bupivacaine DRUG

Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL

Also known as: Exparel

Interscalene nerve block with Liposomal + Bupivacaine 0.5%

0.5% Bupivacaine HCL DRUG

0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

20 mL 0.5% Bupivacaine HCL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Uchenna O. Umeh, MD
• Organization: NYU Langone Health

Uchenna.Umeh@nyulangone.org

(212) 598-6085

Study Officials

• Uchenna Umeh, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: March 1, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date
• 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.

Locations

US (1)