Back to resultsLiposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee arthroplasty, Total joint arthroplasty, Knee replacement, Osteoarthritis of the knee
Eligibility 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)
Sites / Locations
- OhioHealth Grant Medical Center Bone and Joint Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number Physical Therapy Sessions Necessary for Discharge
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
Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
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
Length of Stay (LOS, in Days)
Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
Nausea
Vomiting
Constipation
Ileus
Pruritus
Respiratory depression
Over-sedation
Total Cost of Care (Dollars)
Hospital Readmission Not Including Admissions Planned Procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219087
Brief Title
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total knee arthroplasty, Total joint arthroplasty, Knee replacement, Osteoarthritis of the knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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 Outcome Measure Information:
Title
Number Physical Therapy Sessions Necessary for Discharge
Description
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.
Time Frame
Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Secondary Outcome Measure Information:
Title
Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
Description
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
Time Frame
Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Title
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.
Title
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.
Title
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
Description
Nausea
Vomiting
Constipation
Ileus
Pruritus
Respiratory depression
Over-sedation
Time Frame
Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Title
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.
Title
Hospital Readmission Not Including Admissions Planned Procedures
Time Frame
Participants will be followed for 30 days after leaving the hospital.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Fada, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Jordan, PharmD, BCPS
Organizational Affiliation
OhioHealth
Official's Role
Study Director
Facility Information:
Facility Name
OhioHealth Grant Medical Center Bone and Joint Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
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