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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18952 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral nerve block | Experimental | Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral nerve block | Procedure | All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Nerve Block Success as a Primary Anesthetic | Intraoperative period (typically one to three hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The medical record will be reviewed to assess 30-day mortality. | Changes from baseline through 30 days post-operative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José R Soberón, MD | Malcom Randall VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peripheral Nerve Block | Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed. Peripheral nerve block: All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed. Lateral femoral cutaneous nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. Obturator nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. |
| 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 | Mar 26, 2025 |
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Pilot clinical trial with a single arm
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| Intravenous Sedatives | Drug | Intravenous sedation using propofol or dexmedetomidine will be administered. |
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| Lateral femoral cutaneous nerve blocks | Procedure | After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. |
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| Obturator nerve blocks | Procedure | After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peripheral Nerve Block | Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed. Peripheral nerve block: All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed. Lateral femoral cutaneous nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. Obturator nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | Peripheral Nerve Block Success as a Primary Anesthetic | Posted | Count of Participants | Participants | Intraoperative period (typically one to three hours) |
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| Secondary | Mortality | The medical record will be reviewed to assess 30-day mortality. | Posted | Count of Participants | Participants | Changes from baseline through 30 days post-operative. |
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Adverse events were monitored from informed consent until 30 days after surgery. Active adverse events assessments occurred at Day 30 post-enrollment (±7 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 | Peripheral Nerve Block | Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed. Peripheral nerve block: All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed. Lateral femoral cutaneous nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. Obturator nerve blocks: After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. | 1 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose R. Soberon, Jr., MD | Malcom Randall VAMC/University of Florida | 352-376-1611 | 10-3581 | jose.soberon@va.gov |
| Dec 4, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2019 | Dec 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D006943 | Hyperglycemia |
| D006973 | Hypertension |
| D003324 | Coronary Artery Disease |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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