Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization
|ClinicalTrials.gov Identifier: NCT00903825|
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : January 14, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Local Anesthetics Ultrasound Guidance Catheterization||Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine) Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Active Comparator: Manual palpation
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
Injection of lidocaine before femoral artery catheterization with manual palpation.
Experimental: Ultrasound guidance
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)
Injection of lidocaine (< 10 mls of lidocaine, 1%w/v) before femoral artery puncture with free-hand duplex ultrasound guidance.
- visual analog scale (VAS) for pain evaluation [ Time Frame: immediatelly after sheath placement, days 0-7 ]
- major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding) [ Time Frame: immediate, up to 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903825
|Department of Radiology, Angiography Suite, Patras University Hospital|
|Patras, Achaia, Greece, 26504|
|Study Director:||Dimitris Siablis, Professor||Department of Radiology, Patras University Hospital|