Back to resultsLiposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
0.5% Bupivacaine HCL
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
20 mL 0.5% Bupivacaine HCL
Interscalene nerve block with Liposomal + Bupivacaine 0.5%
Arm Description
Administered in an Interscalene block for TSA
Outcomes
Primary Outcome Measures
Opioid Utilization
Measure in morphine milligram equivalents [MME]
Secondary Outcome Measures
Opioid Utilization
Measure in morphine milligram equivalents [MME]
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03913091
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 mL 0.5% Bupivacaine HCL
Arm Type
Experimental
Arm Title
Interscalene nerve block with Liposomal + Bupivacaine 0.5%
Arm Type
Experimental
Arm Description
Administered in an Interscalene block for TSA
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Intervention Type
Drug
Intervention Name(s)
0.5% Bupivacaine HCL
Intervention Description
0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Primary Outcome Measure Information:
Title
Opioid Utilization
Description
Measure in morphine milligram equivalents [MME]
Time Frame
24-72 hour, Post-Operative Period
Secondary Outcome Measure Information:
Title
Opioid Utilization
Description
Measure in morphine milligram equivalents [MME]
Time Frame
Day 4-7, Post-Operative Period
Title
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
Description
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
Time Frame
Day 1-7, Post-Operative Period
Title
T-Scores, PROMIS Pain Intensity Scale
Description
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.
Time Frame
Day 1-7, Post-Operative Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uchenna Umeh, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
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)
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