Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04974385
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
10.9
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 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 :
Aug 4, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/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 Names:
  • 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

    Primary Outcome Measures

    1. Opioid Consumption [72 hours postoperative]

      Morphine equivalents used during first 72 hours after surgery

    Secondary Outcome Measures

    1. Numeric Rating Scale Reported Pain Scores [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    SiteCityStateCountryPostal Code
    1University of Virginia Medical CenterCharlottesvilleVirginiaUnited States22903

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    • Principal Investigator: Donald A Elmer, MD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    D. Aric Elmer, MD, Principal Investigator, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT04974385
    Other Study ID Numbers:
    • HSR210190
    First Posted:
    Jul 23, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Aug 12, 2021