Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)

NCT02197273 | Completed Results

• 1 other identifier: OH1-14-00529
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis, Shoulder

Keywords

Total knee arthroplasty; Total shoulder arthroplasty; Total hip arthroplasty; Total joint arthroplasty; Hip replacement; Knee replacement; Shoulder replacement

Outcome Measures

Primary Outcomes (1)

• Length of Stay in Hospital (Days)

  Participants were followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes (2)

• Time to Post-operative Rescue Opioids (Hours)

  Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days

• Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days

  Date of discharge through 30 days following discharge

Study Arms (2)

Standard of care analgesia

ACTIVE COMPARATOR

Total Hip Arthroplasty (THA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Knee Arthroplasty (TKA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Shoulder Arthroplasty (TSA): All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.

Drug: Standard of care analgesia

Liposomal bupivacaine

EXPERIMENTAL

THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle

Drug: Liposomal bupivacaine; Drug: Standard of care analgesia

Interventions

Liposomal bupivacaine DRUG

Also known as: Exparel

Liposomal bupivacaine

Standard of care analgesia DRUG

Also known as: Bupivacaine, Ropivacaine, Fentanyl, Solumedrol, Morphine, Saline, Epinephrine

Liposomal bupivacaine; Standard of care analgesia

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of osteoarthritis
• Elected to undergo primary TKA, THA, or TSA

You may not qualify if:

• Age \< 18 years
• Pregnant or breastfeeding
• Non-English speaking
• Unable to give informed consent
• Previous open hip, knee or shoulder surgery
• Pre-determined patients discharging to ECF
• Patients with allergies to bupivacaine
• Patients currently taking opioid pain medication
• Patients with contraindication to nerve blocks
• Patients undergoing simultaneous bilateral joint replacement, as this would require \>1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
• Patients with severe hepatic disease
• Patients with chronic heart disease as defined as a decreased ejection fraction

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Interventions

Bupivacaine; Ropivacaine; Fentanyl; Methylprednisolone Hemisuccinate; Morphine; Sodium Chloride; Epinephrine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

No early termination or technical problems identified.

Results Point of Contact

• Title: Deborah Napier
• Organization: OhioHealth

Deborah.Napier@ohiohealth.com

614-566-5575

Study Officials

• Deborah Napier, BSN,RN,MA

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Outcomes Manager

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 21, 2016
• Results First Posted: October 21, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)