RecruitingPhase 4NCT04454203

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


Sponsor

Duke University

Enrollment

40 participants

Start Date

Feb 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting a local anesthetic near the femoral artery can control a type of high blood pressure that occurs during ankle replacement surgery when a tourniquet (a tight band used to stop blood flow) is applied to the leg. **You may be eligible if:** - You are between 18 and 75 years old - You are scheduled to have total ankle replacement surgery - You are in reasonably good health (not classified as critically ill) - You can communicate your pain levels during and after surgery **You may NOT be eligible if:** - You have chronic pain or use opioid pain medications daily - You are pregnant - You have an allergy to local anesthetic medications - You weigh less than 50 kg (about 110 lbs) - You have a history of substance or alcohol abuse in the past 2 years - You have uncontrolled anxiety, schizophrenia, or other psychiatric conditions - You have a significant medical condition that increases your surgical risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMepivacaine

An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

DRUGSaline

An infiltration of saline superomedially to the femoral artery via perineural catheter.

PROCEDUREPerifemoral Injection of Local Anesthetic

Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

PROCEDUREPerifemoral Injection of Local Anesthetic

Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.


Locations(1)

Duke University Hospital

Durham, North Carolina, United States

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NCT04454203


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