Anesthesia, LocalPhase 4RAOLANCT03072394
Local Anesthesia in Radial Catheterization
A Phase 4 study testing Local anesthetic and local anaesthetic injection in people with Anesthesia, Local and Coronary Artery Disease, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia, Local, Coronary Artery Disease, Catheter Site Discomfort
- What is being tested?
- Local anesthetic and local anaesthetic injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2015to 10 Jan 2021
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referral for elective diagnostic coronary angiography
Who cannot join
- acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal.
Trial locations and contacts
1 site in 1 country.
George Latsios, MD PhD contact
Greece1 site, 1 recruiting
- Recruiting
Hippocration Hospital, Athens University Medical School
Athens, Attica
Dimitris Tousoulis, Ass. Professor, +30 210 7782446, tousouli@med.uoa.gr
George Latsios, MD
About this study
Official title: Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.
Read the detailed description
A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.
Participants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.
Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.
Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group
Participants will be observed for 4 hours post angiography for development of local complications or side effects.
- Being tested
- Local anesthetic, local anaesthetic injection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anestheticDrug
Also called Local anesthetic ointment
Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
local anaesthetic injectionDrug
Also called Skin anethesia by lidocaine injection
Local skin anesthesia during radial coronary artery catheterization by lidocaine injection
| Study group | Role | What they receive |
|---|---|---|
| EMLA anesthetic ointment (AO) | Experimental | In AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse. Receives: Drug: Local anesthetic |
| Local Skin Anesthetic Injection (LA) | Active comparator | In LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture Receives: Drug: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale of Pain Perception during sheath insertion
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Measured: During artery puncture
Visual Analog Scale of Pain Perception after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
Measured: 30 minutes after sheath removal
Secondary outcomes (2)
Puncture efficiency (number of puncture attempts)
The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.
Measured: During radial artery catheterization
Radial artery spasm
The occurrence of radial artery spasm in each group during radial artery catheterization
Measured: During radial artery catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start10 Jan 2015
- Primary completion20 Nov 2020 (estimated)
- Study completion10 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitris Tousoulis, Hippocration General Hospital
- Investigators
- Dimitris Tousoulis, MD PhD, Study director, Professor of CardiologyGeorge Latsios, MD PhD, Principal investigator, Consultant Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072394
- Sponsor's protocol ID
- HippocratioGH
- Acronym
- RAOLA
- Status last verified
- Feb 2018
- First submitted
- 24 Feb 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
- ClinicalTrials.gov ID
- NCT03072394
- Acronym / sponsor ID
- RAOLA / HippocratioGH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 10 Jan 2021 (estimated)
- First posted
- 7 Mar 2017 (actual)
- 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.
A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.
Detailed description
A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.
Participants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.
Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.
Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group
Participants will be observed for 4 hours post angiography for development of local complications or side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA anesthetic ointment (AO) | Experimental | Drug: Local anestheticIn AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse. |
| Local Skin Anesthetic Injection (LA) | Active comparator | Drug: local anaesthetic injectionIn LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- referral for elective diagnostic coronary angiography
Key exclusion criteria (1 listed)
- acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal.
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 |
|---|---|---|
| Local anestheticAlso: Local anesthetic ointmentLocal skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment | Drug | EMLA anesthetic ointment (AO) |
| local anaesthetic injectionAlso: Skin anethesia by lidocaine injectionLocal skin anesthesia during radial coronary artery catheterization by lidocaine injection | Drug | Local Skin Anesthetic Injection (LA) |
Primary outcome
Visual Analog Scale of Pain Perception during sheath insertion
Time frame: During artery puncture
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Visual Analog Scale of Pain Perception after sheath removal
Time frame: 30 minutes after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
2 secondary outcomes
Puncture efficiency (number of puncture attempts)
Time frame: During radial artery catheterization
Radial artery spasm
Time frame: During radial artery catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: No
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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.
George Latsios, MD PhD contact
Dimitris Tousoulis, MD PhD study director
Professor of Cardiology
George Latsios, MD PhD principal investigator
Consultant Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local anesthetic and local anaesthetic injection in people with Anesthesia, Local and Coronary Artery Disease, run by Hippocration General Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2018. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Latsios, MD PhD (glatsios@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale of Pain Perception during sheath insertion (time frame: During artery puncture). The study lists 2 primary outcomes in all. 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 28 Feb 2018; AzTrials last refreshed its copy on 29 Oct 2026.