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)

Phase 4

Completed

• Conditions: Shoulder Pain
• Interventions: Drug: 0.5% Bupivacaine HCL; Drug: Liposomal Bupivacaine

• Registration Number: NCT03913091
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Status Verified: 2022-01
• Results First Submitted: 2022-01-03
• Results First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-03
• Results First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 mL 0.5% Bupivacaine HCL	0.5% Bupivacaine HCL	-
Interscalene nerve block with Liposomal + Bupivacaine 0.5%	Liposomal Bupivacaine	Administered in an Interscalene block for TSA

Primary Outcome Measures

Name	Time	Method
Opioid Utilization	24-72 hour, Post-Operative Period	Measure in morphine milligram equivalents \[MME\]

Secondary Outcome Measures

Name	Time	Method
Opioid Utilization	Day 4-7, Post-Operative Period	Measure in morphine milligram equivalents \[MME\]
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale	Day 1-7, Post-Operative Period	PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5.; 1. = No pain; 2. = Mild; 3. = Moderate; 4. = Severe; 5. = Very Severe
T-Scores, PROMIS Pain Intensity Scale	Day 1-7, Post-Operative Period	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States