Could nerve blocks replace general anesthesia for leg amputations?

NCT ID NCT03404180

Symptom relief Sponsor: University of Florida Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether using nerve blocks and sedation instead of general anesthesia could make upper leg amputation surgery safer for high-risk patients, such as the elderly or those with diabetes or heart disease. Thirty participants received ultrasound-guided nerve blocks and sedation. The goal was to see if this approach could provide effective pain control and reduce complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Peripheral nerve block (procedure) and intravenous sedatives (propofol or dexmedetomidine)
What this could lead to: If successful, this approach could offer a safer alternative to general anesthesia for high-risk patients needing leg amputations, reducing complications and improving pain control.
What could go wrong: This is a small, single-site study with only 30 participants, so results may not apply to all patients. Nerve blocks may not always work as the main anesthetic, and sedation carries its own risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

30 people

The number who actually took part.

Started

Feb 2018

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset coronary artery disorder hyperglycemia hypertensive disorder peripheral vascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Hyperglycaemia (diabetic) Hypertension Peripheral vascular diseases Pulmonary disease, chronic obstructive

Could nerve blocks replace general anesthesia for leg amputations?

What the study statuses mean