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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | 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. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug |
|
| |
| Standard of Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fada, MD | OhioHealth | Principal Investigator |
| Sara Jordan, PharmD, BCPS | OhioHealth | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OhioHealth Grant Medical Center Bone and Joint Center | Columbus | Ohio | 43215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Liposomal bupivacaine |
| FG001 | 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. ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Liposomal bupivacaine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Physical Therapy Sessions | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Liposomal bupivacaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Jordan Clinical Pharmacist for Surgery Services | OhioHealth | 614-461-8174 | sara.jordan@ohiohealth.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
|
| Length of Stay (LOS, in Days) | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
| Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams) | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
| Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay |
| Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
| Total Cost of Care (Dollars) | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
| Hospital Readmission Not Including Admissions Planned Procedures | Participants will be followed for 30 days after leaving the hospital. |
| 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. ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Units on a scale | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
|
|
|
| Secondary | Length of Stay (LOS, in Days) | Posted | Mean | Standard Deviation | Days | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
|
|
|
| Secondary | Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams) | Posted | Mean | Standard Deviation | Milligrams | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
|
|
|
| Secondary | Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay |
| Posted | Number | participants | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
|
|
|
| Secondary | Total Cost of Care (Dollars) | Posted | Median | Full Range | Dollars | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. |
|
|
|
|
| Secondary | Hospital Readmission Not Including Admissions Planned Procedures | Posted | Number | participants | Participants will be followed for 30 days after leaving the hospital. |
|
|
|
| 0 |
| 30 |
| 13 |
| 30 |
| EG001 | 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. ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia | 0 | 29 | 11 | 29 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Oversedation | Nervous system disorders | Systematic Assessment |
|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |