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NCT Number: NCT04974385

Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Liposomal bupivacaine

Drug

Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.

Other names: Exparel

Bupivacaine

Drug

Active comparator as standard of care.

Primary outcomes

  1. Opioid Consumption

    Time frame: 72 hours postoperative

    Morphine equivalents used during first 72 hours after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Nov 3, 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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