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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

Tourniquet HypertensionIntraoperative HypertensionTotal Ankle ArthroplastyAnkle Fusion

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

Inclusion Criteria1

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

Exclusion Criteria12

  • 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

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