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| ID | Type | Description | Link |
|---|---|---|---|
| 11/14.4.2009 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual palpation | Active Comparator | Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique |
|
| Ultrasound guidance | Experimental | Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale (VAS) for pain evaluation | immediatelly after sheath placement, days 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding) | immediate, up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Siablis, Professor | Department of Radiology, Patras University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Angiography Suite, Patras University Hospital | Pátrai | ACHAIA | 26504 | Greece |
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| Injection of femoral local anesthetic (lidocaine) with manual palpation | Procedure | Injection of lidocaine before femoral artery catheterization with manual palpation. |
|
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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