Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

January 13, 2010 updated by: University of Patras

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26504
        • Department of Radiology, Angiography Suite, Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analog scale (VAS) for pain evaluation
Time Frame: immediatelly after sheath placement, days 0-7
immediatelly after sheath placement, days 0-7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (ESTIMATE)

May 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44/27-2-09
  • 11/14.4.2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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