Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

Study Overview
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Brief Summary
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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).

Official Title
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Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial

Conditions
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Local Anesthetics, Ultrasound Guidance, Catheterization

Intervention / Treatment
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* Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine)
* Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for diagnostic intra-arterial procedures Patient scheduled for therapeutic intra-arterial procedures At least 1 palpable femoral artery Patient informed consent Exclusion Criteria: Allergic reaction to iodine contrast media Allergic reaction to lidocaine Bilateral obstruction of femoral arteries Impaired or lost vision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual palpation<br>Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique | Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation<br>* Injection of lidocaine before femoral artery catheterization with manual palpation.<br>|
| Experimental: Ultrasound guidance<br>Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance | Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine)<br>* Injection of lidocaine (< 10 mls of lidocaine, 1%w/v) before femoral artery puncture with free-hand duplex ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale (VAS) for pain evaluation |  | immediatelly after sheath placement, days 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding) |  | immediate, up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral artery puncture, local anesthesia, ultrasound guided