Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

Phase 2

Completed

• Conditions: Local Anesthetics; Ultrasound Guidance; Catheterization
• Interventions: Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation; Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine)

• Registration Number: NCT00903825
• Lead Sponsor: University of Patras

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual palpation	Injection of femoral local anesthetic (lidocaine) with manual palpation	Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique
Ultrasound guidance	Ultrasound guided injection of femoral local anesthetic (lidocaine)	Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance

Primary Outcome Measures

Name	Time	Method
visual analog scale (VAS) for pain evaluation	immediatelly after sheath placement, days 0-7

Secondary Outcome Measures

Name	Time	Method
major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)	immediate, up to 7 days

Trial Locations

Locations (1)

Department of Radiology, Angiography Suite, Patras University Hospital; 🇬🇷 Patras, Achaia, Greece