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OpenTrials
Completed

NCT Number: NCT03404180

Peripheral Nerve Blocks for Above-the-knee Amputations

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).

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Key information

Conditions

Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Disease Coronary Artery Disease Coronary Disease Disease Attributes Glucose Metabolism Disorders Heart Diseases Hyperglycaemia (Diabetic) Hyperglycemia Hypertension Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Intravenous Sedatives

Drug

Intravenous sedation using propofol or dexmedetomidine will be administered.

Other names: Propofol or Dexmedetomidine

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.

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.

Primary outcomes

  1. Peripheral Nerve Block Success as a Primary Anesthetic

    Time frame: Intraoperative period (typically one to three hours)

Secondary outcomes

  1. Mortality

    Time frame: Changes from baseline through 30 days post-operative.

    The medical record will be reviewed to assess 30-day mortality.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Peripheral Nerve Blocks for Upper Leg Amputations

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2018
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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