NCT00903825

Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Local Anesthetics
• Ultrasound Guidance
• Catheterization

Interventions

Type	Name	Description
PROCEDURE	Ultrasound guided injection of femoral local anesthetic (lidocaine)	Injection of lidocaine (\< 10 mls of lidocaine, 1%w/v) before femoral artery puncture with free-hand duplex ultrasound guidance.
PROCEDURE	Injection of femoral local anesthetic (lidocaine) with manual palpation	Injection of lidocaine before femoral artery catheterization with manual palpation.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-05-18
• Last updated: 2010-01-14

Locations

1 site across 1 country: Greece