Status:
RECRUITING
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Lead Sponsor:
Duke University
Conditions:
Tourniquet Hypertension
Intraoperative Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ner...
Detailed Description
This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet. Depending on whether you enr...
Eligibility Criteria
Inclusion
- Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Exclusion
- 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
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 3 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04454203
Start Date
February 5 2021
End Date
February 3 2026
Last Update
February 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Hospital
Durham, North Carolina, United States, 27710