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

Description

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

Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion

Study Overview

Study Details

Study overview

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.

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

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

Condition
Tourniquet Hypertension
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Hospital, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ASA 4 or 5
  • 2. Diagnosis of chronic pain
  • 3. Daily chronic opioid use (over 3 months of continuous opioid use).
  • 4. Inability to communicate pain scores or need for analgesia.
  • 5. Infection at the site of block placement
  • 6. Age under 18 years old or greater than 75 years old
  • 7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)
  • 8. Intolerance/allergy to local anesthetics
  • 9. Weight \<50 kg
  • 10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • 11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • 12. 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Amanda Kumar, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University

William M Bullock, MD, PhD, STUDY_DIRECTOR, Duke University

Study Record Dates

2025-05-01