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This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.
Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACB within true AC with bupivacaine | Active Comparator | The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine |
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| ACB proximal to true AC with bupivacaine | Active Comparator | The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACB within true AC with bupivacaine 0.5% 20cc | Drug | The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents | Amount of morphine equivalents administered intraoperatively in 24 hours | 24 Hours |
| Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents | Amount of morphine equivalents administered postoperatively in 24 hours | 24 Hours |
| Side Effects Such as Nausea, Itching, Constipation. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prianka Desai, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACB Within True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 |
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| ACB proximal to true AC with bupivacaine 0.5% 20cc | Drug | Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine |
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| FG001 |
| ACB Proximal to True AC With Bupivacaine |
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ACB Within True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. |
| BG001 | ACB Proximal to True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents | Amount of morphine equivalents administered intraoperatively in 24 hours | Posted | Mean | Standard Deviation | milligrams of morphine equivalents | 24 Hours |
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| Primary | Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents | Amount of morphine equivalents administered postoperatively in 24 hours | Posted | Mean | Standard Deviation | mg of morphine equivalents | 24 Hours |
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| Primary | Side Effects Such as Nausea, Itching, Constipation. | Posted | Count of Participants | Participants | 24 hours |
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| Secondary | Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months. | This measure was not measured/assessed in study participants; the orthopedic surgeon's office did not perform this test in the clinic at any point of the study. | Posted | 12 months |
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24 hours
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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 | ACB Within True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | ACB Proximal to True AC With Bupivacaine | The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prianka Desai | NYU Langone | 212-263-5072 | prianka.desai@nyulangone.org |
| Dec 1, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Title | Measurements |
|---|---|
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| 36-45 years |
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| 46-55 years |
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| 56-65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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