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Completed

NCT Number: NCT02219087

Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OhioHealth Grant Medical Center Bone and Joint Center

Columbus, Ohio, 43215, 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 knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee 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

  • At least 18 years of age
  • Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator

Exclusion criteria

  • Age <18 years
  • Pregnant or breastfeeding
  • Non-English-speaking
  • Unable to give informed consent
  • Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
  • Patients unable to complete a device-assisted 140 foot walk at baseline
  • Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
  • Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
  • Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)

Treatment and study plan

Liposomal bupivacaine

Drug

Other names: Exparel

Standard of care

Drug

Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.

Primary outcomes

  1. Number Physical Therapy Sessions Necessary for Discharge

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

    Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.

Secondary outcomes

  1. Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

    VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated

  2. Length of Stay (LOS, in Days)

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

  3. Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

  4. Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

    • Nausea
    • Vomiting
    • Constipation
    • Ileus
    • Pruritus
    • Respiratory depression
    • Over-sedation

  5. Total Cost of Care (Dollars)

    Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

  6. Hospital Readmission Not Including Admissions Planned Procedures

    Time frame: Participants will be followed for 30 days after leaving the hospital.

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Registry information

Official study title

Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2014
Registry last updated
Jan 2, 2018

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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