Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT00903825

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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).

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jan 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

visual analog scale (VAS) for pain evaluation [immediatelly after sheath placement, days 0-7]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology, Angiography Suite, Patras University Hospital	Patras	Achaia	Greece	26504

Sponsors and Collaborators

University of Patras

Investigators

Study Director: Dimitris Siablis, Professor, Department of Radiology, Patras University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00903825

Other Study ID Numbers:

44/27-2-09
11/14.4.2009

First Posted:

May 18, 2009

Last Update Posted:

Jan 14, 2010

Last Verified:

May 1, 2009

Keywords provided by , ,

femoral artery puncture

local anesthesia

ultrasound guided

Additional relevant MeSH terms:

Lidocaine

Anesthetics, Local

Anesthetics

Study Results

No Results Posted as of Jan 14, 2010