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)

Shoulder Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913091
• Other study ID #: 18-01183
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: January 19, 2021

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Drug:
• Liposomal Bupivacaine
Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
• 0.5% Bupivacaine HCL
0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Utilization	Measure in morphine milligram equivalents [MME]	24-72 hour, Post-Operative Period
Secondary	Opioid Utilization	Measure in morphine milligram equivalents [MME]	Day 4-7, Post-Operative Period
Secondary	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
Secondary	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