Catheterization, Local Anesthetics, Ultrasound Guidance
Conditions
Keywords
femoral artery puncture, local anesthesia, ultrasound guided
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).
Interventions
PROCEDUREUltrasound 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.
PROCEDUREInjection of femoral local anesthetic (lidocaine) with manual palpation
Injection of lidocaine before femoral artery catheterization with manual palpation.
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analog scale (VAS) for pain evaluation | immediatelly after sheath placement, days 0-7 |
Secondary
| Measure | Time frame |
|---|---|
| major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding) | immediate, up to 7 days |
Countries
Greece
Outcome results
None listed