Indication of Blood Gas Analysis by Radial Artery Blood SamplingPhase 3GAELNCT01964248
Local Anesthesia Before Arterial Puncture for Blood Gas Analysis
A Phase 3 study testing lidocaïne/prilocaïne 5% in people with Indication of Blood Gas Analysis by Radial Artery Blood Sampling, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication of Blood Gas Analysis by Radial Artery Blood Sampling
- What is being tested?
- lidocaïne/prilocaïne 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Oct 2015
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve
- Patients capable of estimating the pain felt with numeric pain intensity scale
- Patients with numeric pain intensity scale = 0 before sample of blood
- Patients with no contraindication or no allergy of an anesthetic such as lidocaine
Who cannot join
- Patients aged less than 18 years old
- Patients incapable of estimating the pain felt with numeric pain intensity scale
- Patients with numeric pain intensity scale > 0 before sample of blood
- Patients for whom the arterial taking is impossible for the level radial nerve
- Hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream
- Porphyries known
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study
The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.
Read the detailed description
In an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of Pneumology 1 / septic Thoracic and vascular Cardiac Surgery.
The arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. This act appears at the top of the anticipated care as painful by the nursing teams.
In the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. Other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. Finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population.
In this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.
- Being tested
- Placebo, lidocaïne/prilocaïne 5%
- Keywords
- Blood gas analysis, Arterial puncture, Local anesthesia, Eutectic mixture, Lidocaïne/prilocaïne cream (5%), Placebo, Pain Intensity Scale, Numerical Rating Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Application placebo cream 2 hours before blood sample
Placebo cream applied 2 hours before blood sample
lidocaïne/prilocaïne 5%Drug
Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample
| Study group | Role | What they receive |
|---|---|---|
| Lidocaïne/prilocaïne | Experimental | * Lidocaine/prilocaine eutectic mixture 5% incorporated in a cream base
* Single dose: 2 grams (one tube of cream)
* Cream applied 2 hours before blood sample Receives: Drug: lidocaïne/prilocaïne 5% |
| Placebo | Placebo comparator | * Single dose: 2 grams (one tube of cream)
* Cream applied 2 hours before blood sample Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
interest of local anesthesia (lidocaïne/prilocaïne)
Determine the interest of local anesthesia with association of lidocaïne/prilocaïne before arteriel puncture for gas analysis
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indication of Blood Gas Analysis by Radial Artery Blood SamplingStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Francis COUTURAUD, Professor, Principal investigator, Hôpital Morvan, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964248
- Sponsor's protocol ID
- RB 12.011 (GAEL)
- Acronym
- GAEL
- Status last verified
- Oct 2015
- First submitted
- 25 Jul 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.
PubMed 33758058
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study
- ClinicalTrials.gov ID
- NCT01964248
- Acronym / sponsor ID
- GAEL / RB 12.011 (GAEL)
- Keywords
- Blood gas analysis, Arterial puncture, Local anesthesia, Eutectic mixture, Lidocaïne/prilocaïne cream (5%), Placebo, Pain Intensity Scale, Numerical Rating Scale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Oct 2013 (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 the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.
Detailed description
In an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of Pneumology 1 / septic Thoracic and vascular Cardiac Surgery.
The arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. This act appears at the top of the anticipated care as painful by the nursing teams.
In the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. Other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. Finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population.
In this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaïne/prilocaïne | Experimental | Drug: lidocaïne/prilocaïne 5%* Lidocaine/prilocaine eutectic mixture 5% incorporated in a cream base * Single dose: 2 grams (one tube of cream) * Cream applied 2 hours before blood sample |
| Placebo | Placebo comparator | Drug: Placebo* Single dose: 2 grams (one tube of cream) * Cream applied 2 hours before blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve
- Patients capable of estimating the pain felt with numeric pain intensity scale
- Patients with numeric pain intensity scale = 0 before sample of blood
- Patients with no contraindication or no allergy of an anesthetic such as lidocaine
Key exclusion criteria (7 listed)
- Patients aged less than 18 years old
- Patients incapable of estimating the pain felt with numeric pain intensity scale
- Patients with numeric pain intensity scale > 0 before sample of blood
- Patients for whom the arterial taking is impossible for the level radial nerve
- Hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream
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 |
|---|---|---|
| PlaceboAlso: Application placebo cream 2 hours before blood samplePlacebo cream applied 2 hours before blood sample | Drug | Placebo |
| lidocaïne/prilocaïne 5%Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample | Drug | Lidocaïne/prilocaïne |
Primary outcome
interest of local anesthesia (lidocaïne/prilocaïne)
Time frame: 1 hour
Determine the interest of local anesthesia with association of lidocaïne/prilocaïne before arteriel puncture for gas analysis
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 16 Oct 2015.
- Derived from this study: PubMed 33758058Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.
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.
Francis COUTURAUD, Professor principal investigator
Hôpital Morvan, CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lidocaïne/prilocaïne 5% in people with Indication of Blood Gas Analysis by Radial Artery Blood Sampling, run by University Hospital, Brest at 1 site in France.
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 7 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 16 Oct 2015. 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 France. 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. Some participants in this study may receive a placebo. 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 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?
interest of local anesthesia (lidocaïne/prilocaïne) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964248, which also lists 1 linked publication.
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 16 Oct 2015.