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Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04974385
Recruitment Status : Completed
First Posted : July 23, 2021
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
D. Aric Elmer, MD, University of Virginia

Study Description
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Brief Summary:
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Liposomal bupivacaine Drug: Bupivacaine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
Actual Study Start Date : August 4, 2021
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : May 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Liposomal Bupivacaine
Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
 Drug: Liposomal bupivacaine
Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.
Other Name: Exparel

Drug: Bupivacaine
Active comparator as standard of care.
Active Comparator: Non-liposomal Bupivacaine
Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine
 Drug: Bupivacaine
Active comparator as standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 72 hours postoperative ]
    Morphine equivalents used during first 72 hours after surgery


Secondary Outcome Measures :
  1. Numeric Rating Scale Reported Pain Scores [ Time Frame: 72 hours postoperative ]
    Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain

  2. Nerve Block Related Adverse Events [ Time Frame: 72 hours postoperative ]
    Any adverse event determined to be caused as a result of having a nerve block to include but not limited to toxicity, allergic reaction, nerve injury.

  3. Patients with Additional, Unanticipated Pain Related Medical Encounters [ Time Frame: 72 hours postoperative ]
    Any unanticipated, unplanned, pain related phone calls to surgeon or anesthesiologist for rescue pain treatment, pain related emergency department visits or primary care physician visits for pain treatment

  4. Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale [ Time Frame: 72 hours postoperative ]
    Patient reported satisfaction with their postoperative pain control using the numeric rating scale from 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18 years of age or older
  • Undergoing total shoulder arthroplasty
  • Willing and able to sign consent form to participate in study

Exclusion Criteria:

  • < 18 years of age
  • Unwilling or unable to sign consent form to participate in study
  • Allergy to local anesthetic
  • Medical contraindication to interscalene nerve block
  • Chronic opioid use
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974385


Locations
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United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Donald A Elmer, MD University of Virginia
More Information
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Responsible Party: D. Aric Elmer, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT04974385    
Other Study ID Numbers: HSR210190
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents