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Completed

NCT Number: NCT03913091

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine

Drug

Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL

Other names: Exparel

0.5% Bupivacaine HCL

Drug

0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

Primary outcomes

  1. Opioid Utilization

    Time frame: 24-72 hour, Post-Operative Period

    Measure in morphine milligram equivalents [MME]

Secondary outcomes

  1. Opioid Utilization

    Time frame: Day 4-7, Post-Operative Period

    Measure in morphine milligram equivalents [MME]

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

    Time frame: Day 1-7, Post-Operative Period

    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

  3. T-Scores, PROMIS Pain Intensity Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2019
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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