Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

University of Patras

Status and phase: Completed; Phase 3; Phase 2

Conditions: Local Anesthetics; Ultrasound Guidance; Catheterization

Treatments: Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine); Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation

Study type: Interventional

Funder types: Other

Identifiers

NCT00903825

11/14.4.2009

44/27-2-09

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Manual palpation

Active Comparator group

Description:

Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique

Treatment:

Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation

Ultrasound guidance

Experimental group

Description:

Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance

Treatment:

Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine)