Peripheral Nerve Blocks for Above-the-knee Amputations

University of Florida

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Hypertension; Hyperglycaemia (Diabetic); Peripheral Vascular Diseases; Pulmonary Disease, Chronic Obstructive

Treatments: Procedure: Obturator nerve blocks; Drug: Intravenous Sedatives; Procedure: Peripheral nerve block; Procedure: Lateral femoral cutaneous nerve blocks

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03404180

OCR18952 (Other Identifier)

IRB201702402

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Peripheral nerve block

Experimental group

Description:

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.

Treatment:

Procedure: Lateral femoral cutaneous nerve blocks

Procedure: Peripheral nerve block

Drug: Intravenous Sedatives

Procedure: Obturator nerve blocks