Coronary Artery Disease, Hyperglycaemia (Diabetic), Hypertension, Peripheral Vascular Diseases, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREPeripheral 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.
DRUGIntravenous Sedatives
Intravenous sedation using propofol or dexmedetomidine will be administered.
PROCEDURELateral 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.
PROCEDUREObturator 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.
Sponsors
US Department of Veterans Affairs
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Pilot clinical trial with a single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing above-the-knee amputation or knee disarticulation * Ability to understand and provide informed consent
Exclusion criteria
* Patient refusal or inability to provide informed consent * True allergy, not sensitivity, to any of the following substances: * \- Local anesthetics * \- Propofol or other sedative agents * \- General anesthetic agents * Pregnancy * Severe hepatic impairment * Evidence of infection at or near the proposed needle insertion site * Any sensorimotor deficit, whether acute or chronic, as determined by the PI * Chronic use of opioid medication * BMI ≥ 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral Nerve Block Success as a Primary Anesthetic | Intraoperative period (typically one to three hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Changes from baseline through 30 days post-operative. | The medical record will be reviewed to assess 30-day mortality. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Peripheral Nerve Block | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 22 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 69.9 years STANDARD_DEVIATION 8.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Peripheral Nerve Block Success as a Primary Anesthetic
Time frame: Intraoperative period (typically one to three hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral Nerve Block | Peripheral Nerve Block Success as a Primary Anesthetic | 1 Participants |
Secondary
Mortality
The medical record will be reviewed to assess 30-day mortality.
Time frame: Changes from baseline through 30 days post-operative.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral Nerve Block | Mortality | 1 Participants |