Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

NCT00903825 | Completed Phase 2

• 2 other identifiers: 44/27-2-0911/14.4.2009
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Local Anesthetics; Ultrasound Guidance; Catheterization

Keywords

femoral artery puncture; local anesthesia; ultrasound guided

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS) for pain evaluation

  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)

  immediate, up to 7 days

Study Arms (2)

Manual palpation

ACTIVE COMPARATOR

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

Ultrasound guidance

EXPERIMENTAL

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)

Interventions

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.

Ultrasound guidance

Injection of femoral local anesthetic (lidocaine) with manual palpation PROCEDURE

Injection of lidocaine before femoral artery catheterization with manual palpation.

Manual palpation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for diagnostic intra-arterial procedures
• Patient scheduled for therapeutic intra-arterial procedures
• At least 1 palpable femoral artery
• Patient informed consent

You may not qualify if:

• Allergic reaction to iodine contrast media
• Allergic reaction to lidocaine
• Bilateral obstruction of femoral arteries
• Impaired or lost vision

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Department of Radiology, Angiography Suite, Patras University Hospital

Pátrai, ACHAIA, 26504, Greece

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dimitris Siablis, Professor

  Department of Radiology, Patras University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 14, 2010

Record last verified: 2009-05

Locations

GR (1)