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Completed

NCT Number: NCT02197273

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Shoulder Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

About this study

Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Liposomal bupivacaine

Drug

Other names: Exparel

Standard of care analgesia

Drug

Other names: Bupivacaine, Ropivacaine, Fentanyl, Solumedrol, Morphine, Saline, Epinephrine

Primary outcomes

  1. Length of Stay in Hospital (Days)

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

Secondary outcomes

  1. Time to Post-operative Rescue Opioids (Hours)

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

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

    Time frame: Date of discharge through 30 days following discharge

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Registry information

Official study title

Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2014
Registry last updated
Oct 21, 2016

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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