Local Anesthesia Before Arterial Puncture for Blood Gas Analysis

NCT ID: NCT01964248

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Indication of Blood Gas Analysis by Radial Artery Blood Sampling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaïne/prilocaïne

* 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

Group Type EXPERIMENTAL

lidocaïne/prilocaïne 5%

Intervention Type DRUG

Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample

Placebo

* Single dose: 2 grams (one tube of cream)
* Cream applied 2 hours before blood sample

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo cream applied 2 hours before blood sample

Interventions

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Placebo

Placebo cream applied 2 hours before blood sample

Intervention Type DRUG

lidocaïne/prilocaïne 5%

Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample

Intervention Type DRUG

Other Intervention Names

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Application placebo cream 2 hours before blood sample

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis COUTURAUD, Professor

Role: PRINCIPAL_INVESTIGATOR

Hôpital Morvan, CHRU de Brest

Locations

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Monocentric study

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33758058 (View on PubMed)

Other Identifiers

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RB 12.011 (GAEL)

Identifier Type: -

Identifier Source: org_study_id

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