Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903825
• Other study ID #: 44/27-2-09
• Secondary ID: 11/14.4.2009
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 14, 2009
• Last updated: January 13, 2010
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2009
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheterization
• Local Anesthetics
• Ultrasound Guidance

Intervention

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.
• Injection of femoral local anesthetic (lidocaine) with manual palpation
Injection of lidocaine before femoral artery catheterization with manual palpation.

Locations

Country	Name	City	State
Greece	Department of Radiology, Angiography Suite, Patras University Hospital	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale (VAS) for pain evaluation		immediatelly after sheath placement, days 0-7	No
Secondary	major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)		immediate, up to 7 days	Yes