Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization
NCT ID: NCT00903825
Last Updated: 2010-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2009-01-31
2010-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Manual palpation
Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique
Injection of femoral local anesthetic (lidocaine) with manual palpation
Injection of lidocaine before femoral artery catheterization with manual palpation.
Ultrasound guidance
Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patient scheduled for therapeutic intra-arterial procedures
* At least 1 palpable femoral artery
* Patient informed consent
Exclusion Criteria
* Allergic reaction to lidocaine
* Bilateral obstruction of femoral arteries
* Impaired or lost vision
18 Years
85 Years
ALL
No
Sponsors
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University of Patras
OTHER
Responsible Party
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Patras University Hospital
Principal Investigators
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Dimitris Siablis, Professor
Role: STUDY_DIRECTOR
Department of Radiology, Patras University Hospital
Locations
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Department of Radiology, Angiography Suite, Patras University Hospital
Pátrai, ACHAIA, Greece
Countries
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Other Identifiers
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11/14.4.2009
Identifier Type: -
Identifier Source: secondary_id
44/27-2-09
Identifier Type: -
Identifier Source: org_study_id
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