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OpenTrials
Completed

NCT Number: NCT00903825

Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Radiology, Angiography Suite, Patras University Hospital

Pátrai, ACHAIA, 26504, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided injection of femoral local anesthetic (lidocaine)

Procedure

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

Procedure

Injection of lidocaine before femoral artery catheterization with manual palpation.

Primary outcomes

  1. visual analog scale (VAS) for pain evaluation

    Time frame: immediatelly after sheath placement, days 0-7

Secondary outcomes

  1. major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)

    Time frame: immediate, up to 7 days

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 18, 2009
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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