NCT03404180

Peripheral Nerve Blocks for Above-the-knee Amputations

Peripheral Nerve Blocks for Upper Leg Amputations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Diseases
• Hyperglycaemia (Diabetic)
• Hypertension
• Coronary Artery Disease
• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Intravenous Sedatives	Intravenous sedation using propofol or dexmedetomidine will be administered.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2018-02-09
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2018-01-19
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study