Status:

COMPLETED

Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension

Lead Sponsor:

Duke University

Conditions:

Tourniquet Hypertension

Intraoperative Hypertension

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decrease...

Detailed Description

The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decrease...

Eligibility Criteria

Inclusion

  • Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

Exclusion

  • ASA 4 or 5
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use).
  • Inability to communicate pain scores or need for analgesia.
  • Infection at the site of block placement
  • Age under 18 years old or greater than 75 years old
  • Pregnant women (as determined by standard of care day-of surgery urine bHCG)
  • Intolerance/allergy to local anesthetics
  • Weight \<50 kg
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Key Trial Info

Start Date :

May 3 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 28 2018

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT03390426

Start Date

May 3 2018

End Date

October 28 2018

Last Update

May 5 2021

Active Locations (1)

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1

Duke University Hospital

Durham, North Carolina, United States, 27713