A Phase 4 interventional study of Peripheral nerve block and Intravenous Sedatives in Peripheral Vascular Diseases, Hyperglycaemia (Diabetic) and Hypertension, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by University of Florida · Phase 4, Interventional, and Basic science
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.
Exclusion Criteria:
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.
Procedure: Peripheral nerve block · Drug: Intravenous Sedatives · Procedure: Lateral femoral cutaneous nerve blocks · Procedure: Obturator nerve blocks
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.
Intravenous sedation using propofol or dexmedetomidine will be administered.
Also known as: Propofol or Dexmedetomidine
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.
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.
Peripheral Nerve Block Success as a Primary Anesthetic
Time frame: Intraoperative period (typically one to three hours)
Mortality
The medical record will be reviewed to assess 30-day mortality.
Time frame: Changes from baseline through 30 days post-operative.
| Milestone | Peripheral Nerve Block |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
| Participants | Peripheral Nerve Block |
|---|---|
| Peripheral Nerve Block Success as a Primary Anesthetic | 1 |
The medical record will be reviewed to assess 30-day mortality.
| Participants | Peripheral Nerve Block |
|---|---|
| Mortality | 1 |
Collected over Adverse events were monitored from informed consent until 30 days after surgery. Active adverse events assessments occurred at Day 30 post-enrollment (±7 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peripheral Nerve Block | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Peripheral Nerve Block |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 22 |
| Age, Continuous(years) | Peripheral Nerve Block |
|---|---|
| Mean | 69.9 ± 8.7 |
| Sex: Female, Male(Participants) | Peripheral Nerve Block |
|---|---|
| Female | 0 |
| Male | 30 |
| Race and Ethnicity Not Collected(Participants) | Peripheral Nerve Block |
|---|
| Region of Enrollment(Participants) | Peripheral Nerve Block |
|---|---|
| United States | 30 |
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University of Florida