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Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.
The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.
Hypothesis Statement:
Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine liposome suspension | Experimental | bupivacaine liposome suspension periarticular injection |
|
| concentrated multi drug injection | Active Comparator | concentrated multi drug periarticular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine liposome suspension | Drug | bupivacaine liposome suspension periarticular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (Visual Analog Pain Scores) | visual analog pain scores (scale 0=no pain; 10=worst pain imaginable) | 1 day following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MS04 Equivalent Consumption | in hospital total MS04 equivalent consumption | 1 day following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine Liposome Suspension | bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection |
| FG001 | Concentrated Multi Drug Injection | concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Men and women aged 18 and up receiving total knee arthroplasty for degenerative joint disease
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine Liposome Suspension | bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection |
| BG001 | Concentrated Multi Drug Injection |
| 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 | Pain Scores (Visual Analog Pain Scores) | visual analog pain scores (scale 0=no pain; 10=worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | 1 day following surgery |
|
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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 | Bupivacaine Liposome Suspension | bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela N Fellner PhD CCRP | TriHealth Hatton Research Institute | 513-862-2330 | Angie_Fellner@trihealth.com |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL | Drug | Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl |
|
|
concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
| Secondary | MS04 Equivalent Consumption | in hospital total MS04 equivalent consumption | Posted | Median | Inter-Quartile Range | mg | 1 day following surgery |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Concentrated Multi Drug Injection | concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl | 0 | 35 | 0 | 35 |
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| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |