Catheterization Clinical Trial
Official title:
Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial
The aim of this study is to evaluate the optimization of local anesthetic effect with duplex
ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or
therapeutic interventional procedures.
In total, 200 patients scheduled for various diagnostic or therapeutic interventional
radiology procedures requiring femoral artery puncture, will be randomized in two groups
after informed consent. Patients will be randomized to undergo groin local anesthesia with
the proposed method of duplex ultrasound guided injection of lidocaine versus standard
injection of lidocaine with manual palpation (control group).
The protocol includes the registration of patients' demographics (age, gender, risk factors
for peripheral arterial disease), arterial morphological characteristics (calcifications and
presence of atheromatous disease), as well as technical details of the procedure (total
puncture duration, sheath size, antegrade/retrograde puncture, etc.)
Primary study endpoint will be peri-procedural pain that will be assessed with the use of a
visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary
study endpoints will evaluate procedural safety and complications during the immediate
post-procedural period (up to 7 days).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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