Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome

NCT04134442 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: H00016941
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.

Conditions

Osteoarthritis of the Shoulder; Shoulder Pain; Pain, Postoperative

Keywords

Exparel; Bupivacaine Liposome; Total Shoulder Replacement; Pain Management

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalent Dose of Opioids

  Morphine equivalent dose (MED) of opioids within the first 24 hours after surgery (including PACU and medications on the floor)

  First 24 hours

Secondary Outcomes (6)

• Morphine equivalent dose of opioids

  24-48 hours

• Visual Analogue Scale Pain Score

  24-48 hours

• Hospital Length of Stay

  Through study completion, an average of 2-3 days

• Post-Operative Brief Pain Inventory Short Form

  <1 day, 1 day, and 2 days

• Cost Analysis

  Through study completion, an average of 2-3 days

Study Arms (2)

Bupivacaine Liposome

EXPERIMENTAL

1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist). 2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%

Drug: Bupivacaine Liposome Injection

Standard therapy

ACTIVE COMPARATOR

1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist). 2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.

Other: Standard Therapy

Interventions

Bupivacaine Liposome Injection DRUG

1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist) 2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%

Also known as: Standard Therapy and Bupivacaine Liposome 10ml 1.33%

Bupivacaine Liposome

Standard Therapy OTHER

1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist) 2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or reverse TSR surgery.
• Meet criteria for regional nerve block.
• Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing below 3mg/kg).

You may not qualify if:

• Recent drug use
• Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control).
• Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.
• Coagulopathy
• Subjects with significant liver disease (as amide type local anesthetics such as bupivacaine are metabolized by the liver).
• Infection near or in the area of the nerve block.
• Subject refusal of regional anesthesia.
• Vulnerable populations (prisoners, mental impairment / dementia, etc).
• Subjects requiring interpreter services (not proficient in English).
• Subjects with poor cardio-pulmonary reserve who might not tolerate a hemi-diaphragmatic paralysis or hemi-diaphragmatic paresis.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative; Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexander Chan, MD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle-Investigator

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 22, 2019
• Study Start: December 9, 2019
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

US (1)