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Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219087
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Fada, MD, OhioHealth

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Liposomal bupivacaine Drug: Standard of Care Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Liposomal Bupivacaine
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
 Drug: Liposomal bupivacaine
Other Name: Exparel
Active Comparator: Standard of Care
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.
 Drug: Standard of Care
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. ]
    1. Nausea
    2. Vomiting
    3. Constipation
    4. Ileus
    5. Pruritus
    6. Respiratory depression
    7. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219087


Locations
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United States, Ohio
OhioHealth Grant Medical Center Bone and Joint Center
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Robert Fada, MD OhioHealth
Study Director: Sara Jordan, PharmD, BCPS OhioHealth
More Information
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Responsible Party: Robert Fada, MD, Orthopedic Surgeon, OhioHealth
ClinicalTrials.gov Identifier: NCT02219087    
Other Study ID Numbers: 14-0024
First Posted: August 18, 2014    Key Record Dates
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Robert Fada, MD, OhioHealth:
Total knee arthroplasty
Total joint arthroplasty
Knee replacement
Osteoarthritis of the knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents