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Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT00903825
First received: May 14, 2009
Last updated: January 13, 2010
Last verified: May 2009
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • visual analog scale (VAS) for pain evaluation [ Time Frame: immediatelly after sheath placement, days 0-7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding) [ Time Frame: immediate, up to 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903825

Locations
Greece
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
  More Information

No publications provided

Responsible Party: Siablis Dimitrios, Professor of Radiology, Patras University Hospital
ClinicalTrials.gov Identifier: NCT00903825     History of Changes
Other Study ID Numbers: 44/27-2-09, 11/14.4.2009
Study First Received: May 14, 2009
Last Updated: January 13, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
femoral artery puncture
local anesthesia
ultrasound guided

Additional relevant MeSH terms:
Anesthetics, Local
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013