Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

NCT04974385 | Completed Phase 3

• 1 other identifier: HSR210190
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Morphine equivalents used during first 72 hours after surgery

  72 hours postoperative

Secondary Outcomes (4)

• Numeric Rating Scale Reported Pain Scores

  72 hours postoperative

• Nerve Block Related Adverse Events

  72 hours postoperative

• Patients with Additional, Unanticipated Pain Related Medical Encounters

  72 hours postoperative

• Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale

  72 hours postoperative

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.

Drug: Liposomal bupivacaine; Drug: Bupivacaine

Non-liposomal Bupivacaine

ACTIVE COMPARATOR

Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

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

Also known as: Exparel

Liposomal Bupivacaine

Bupivacaine DRUG

Active comparator as standard of care.

Liposomal Bupivacaine; Non-liposomal Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Donald A Elmer, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 23, 2021
• Study Start: August 4, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 4, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)