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Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery
This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.
266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.
It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposome Bupivacaine, | Experimental | Liposome Bupivacaine 266mg, Knee Infiltration |
|
| Bupivacaine HCl | Active Comparator | Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome Bupivacaine | Drug | Administered via local tissue infiltration around the knee joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity at Movement | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | 24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity at Rest | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | 24hrs |
| Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Marino, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin | Valley Stream | New York | 11580 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Liposomal Bupivacaine 266mg Knee Infiltration Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint. |
| FG001 | Bupivacaine HCl | Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine, | Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint. |
| BG001 | Bupivacaine HCl |
| 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 Intensity at Movement | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | Posted | Mean | 95% Confidence Interval | VAS Scale | 24hrs |
|
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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 | Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PONV | Gastrointestinal disorders | Systematic Assessment | Postoperative nausea and vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research, Anesthesiology | Northwell Health | 718-470-7630 | odowling@northwell.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine HCl | Drug | Administered via CFNB |
|
|
| 24hrs |
| Mean Plasma Bupivicaine Level | 72hrs |
| Mean Plasma Bupivacaine Levels | 48hrs |
| Mean Plasma Bupivacaine Level | 24hrs |
| Mean Plasma Bupivacaine Level | 12hrs |
| Mean Plasma Bupivacaine Level | 4hrs |
| Mean Plasma Bupivacaine Level | 2hrs |
| Mean Plasma Bupivacaine Level | Baseline |
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
Bupivacaine HCl: Administered via CFNB.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Count of Participants |
|
| BMI, Continuous | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Intensity at Rest | Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome. | Posted | Mean | 95% Confidence Interval | VAS Scale | 24hrs |
|
|
|
| Secondary | Opioid Consumption | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents | 24hrs |
|
|
|
| Secondary | Mean Plasma Bupivicaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 72hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Levels | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 48hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 24hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 12hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 4hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Standard Deviation | microgram per mL | 2hrs |
|
|
|
| Secondary | Mean Plasma Bupivacaine Level | Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw | Posted | Mean | Full Range | microgram per mL | Baseline |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 16 |
| 32 |
| EG001 | Bupivacaine HCl | Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB | 0 | 33 | 0 | 33 | 25 | 33 |
| Hypotension | Nervous system disorders | Non-systematic Assessment |
|
| Chest Pains | Cardiac disorders | Non-systematic Assessment |
|
| Somnolence | General disorders | Systematic Assessment |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Knee Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |