Local AnestheticsPhase 2/3NCT00903825
Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization
A Phase 2/3 study testing Ultrasound guided injection of femoral local anesthetic (lidocaine) and Injection of femoral local anesthetic (lidocaine) with manual palpation in people with Local Anesthetics and Ultrasound Guidance, run by University of Patras at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Local Anesthetics, Ultrasound Guidance, Catheterization
- What is being tested?
- Ultrasound guided injection of femoral local anesthetic (lidocaine) and Injection of femoral local anesthetic (lidocaine) with manual palpation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for diagnostic intra-arterial procedures
- Patient scheduled for therapeutic intra-arterial procedures
- At least 1 palpable femoral artery
- Patient informed consent
Who cannot join
- Allergic reaction to iodine contrast media
- Allergic reaction to lidocaine
- Bilateral obstruction of femoral arteries
- Impaired or lost vision
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Radiology, Angiography Suite, Patras University Hospital
Pátrai, ACHAIA, 26504
About this study
Official title: Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial
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).
Read more
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
- Being tested
- Ultrasound guided injection of femoral local anesthetic (lidocaine), Injection of femoral local anesthetic (lidocaine) with manual palpation
- Keywords
- femoral artery puncture, local anesthesia, ultrasound guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injection of femoral local anesthetic (lidocaine)Procedure or surgery
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 palpationProcedure or surgery
Injection of lidocaine before femoral artery catheterization with manual palpation.
| Study group | Role | What they receive |
|---|---|---|
| Manual palpation | Active comparator | Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique Receives: 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 Receives: Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) for pain evaluation
Measured: 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)
Measured: immediate, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Investigators
- Dimitris Siablis, Professor, Study director, Department of Radiology, Patras University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903825
- Sponsor's protocol ID
- 44/27-2-09
- Other IDs
- 11/14.4.2009
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00903825
- Acronym / sponsor ID
- 44/27-2-09
- Conditions
- Local Anesthetics, Ultrasound Guidance, Catheterization
- Keywords
- femoral artery puncture, local anesthesia, ultrasound guided
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual palpation | Active comparator | Procedure: Injection of femoral local anesthetic (lidocaine) with manual palpationLocal anesthetic before femoral artery puncture will be injected with the classic manual palpation technique |
| Ultrasound guidance | Experimental | Procedure: Ultrasound guided injection of femoral local anesthetic (lidocaine)Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient scheduled for diagnostic intra-arterial procedures
- Patient scheduled for therapeutic intra-arterial procedures
- At least 1 palpable femoral artery
- Patient informed consent
Key exclusion criteria (4 listed)
- Allergic reaction to iodine contrast media
- Allergic reaction to lidocaine
- Bilateral obstruction of femoral arteries
- Impaired or lost vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Ultrasound guidance |
| Injection of femoral local anesthetic (lidocaine) with manual palpationInjection of lidocaine before femoral artery catheterization with manual palpation. | Procedure or surgery | Manual palpation |
Primary outcome
visual analog scale (VAS) for pain evaluation
Time frame: immediatelly after sheath placement, days 0-7
1 secondary outcome
major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)
Time frame: immediate, up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Siablis, Professor study director
Department of Radiology, Patras University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ultrasound guided injection of femoral local anesthetic (lidocaine) and Injection of femoral local anesthetic (lidocaine) with manual palpation in people with Local Anesthetics and Ultrasound Guidance, run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) for pain evaluation (time frame: immediatelly after sheath placement, days 0-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.