Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT04454203

Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

Led by Duke University · Updated on 2026-03-23

40

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

CONDITIONS

Official Title

Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • English speaking patients aged 18 to 75 years
  • ASA physical status classification 1 to 3
  • Patients undergoing total ankle arthroplasty surgery
Not Eligible

You will not qualify if you...

  • ASA physical status classification 4 or 5
  • Diagnosis of chronic pain
  • Daily chronic opioid use for over 3 months
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site where the nerve block would be placed
  • Age under 18 or over 75 years
  • Pregnant women
  • Allergy or intolerance to local anesthetics
  • Body weight less than 50 kg
  • Known or suspected addiction or abuse of illicit drugs, prescription medicines, or alcohol within the past 2 years
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorders interfering with assessments or compliance
  • Any clinically significant disease or condition increasing surgical risk or complicating postoperative recovery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University Hospital

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

W

William M Bullock, MD, PhD

CONTACT

J

Jeff C Gadsden, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension | DecenTrialz