Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Duke University · NCT04454203
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- February 5, 2021
- Record last updated
- March 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Mepivacaine; Saline; Perifemoral Injection of Local Anesthetic; Perifemoral Injection of Local Anesthetic
Conditions: Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Exclusion Criteria
- 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
Recruiting US locations
Duke University Hospital
Durham, NC 27710
Site contact: William M Bullock, MD, PhD · 919-681-6437 · william.bullock@duke.edu
Study contacts (from the official record)
- William M Bullock, MD, PhD · 919-681-6437 · william.bullock@duke.edu
- Jeff C Gadsden, MD · 919-681-6437 · jeff.gadsden@duke.edu
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