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Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
RecruitingPhase 4Healthy volunteers welcome
Who can join
Ages 18 to 75 · All sexes · Healthy volunteers welcome
Full eligibility 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: 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
About the study
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.
What is being tested
- Mepivacaine (drug)
- Saline (drug)
- Perifemoral Injection of Local Anesthetic (procedure)
- Perifemoral Injection of Local Anesthetic (procedure)
Sponsor: Duke University · Participants: 40 · Started: Feb 5, 2021
Contact the study team
- William M Bullock, MD, PhD · Phone: 919-681-6437
- Jeff C Gadsden, MD · Phone: 919-681-6437
Official record on ClinicalTrials.gov — NCT04454203
Locations in the U.S.
| North Carolina | Duke University Hospital, Durham |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.