Peripheral Nerve Blocks for Above-the-knee Amputations

NCT03404180 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB201702402OCR18952
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Peripheral Nerve Block Success as a Primary Anesthetic

  Intraoperative period (typically one to three hours)

Secondary Outcomes (1)

• Mortality

  Changes from baseline through 30 days post-operative.

Study Arms (1)

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.

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

Interventions

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.

Peripheral nerve block

Intravenous Sedatives DRUG

Intravenous sedation using propofol or dexmedetomidine will be administered.

Also known as: Propofol or Dexmedetomidine

Peripheral nerve block

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.

Peripheral nerve block

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.

Peripheral nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing above-the-knee amputation or knee disarticulation
• Ability to understand and provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Hyperglycemia; Hypertension; Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jose R. Soberon, Jr., MD
• Organization: Malcom Randall VAMC/University of Florida

jose.soberon@va.gov

352-376-1611

Study Officials

• José R Soberón, MD

  Malcom Randall VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot clinical trial with a single arm

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 19, 2018
• Study Start: February 9, 2018
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)