Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Completed · Phase 4 · Has a placebo group
Conditions studied: Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
In brief
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.
Key facts
- Study ID
- NCT03390426
- Run by
- Duke University
- People needed
- 31
- Starts
- 2018-05-03
- Expected to finish
- 2018-10-28
- Last updated by the study team
- 2021-05-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
You may not qualify if…
- 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
Where it is running
- Duke University Hospital — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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