Clinical trial NCT01964248: Local Anesthesia Before Arterial Puncture for Blood Gas Analysis
Official title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Indication of Blood Gas Analysis by Radial Artery Blood Sampling
Keywords: Blood gas analysis
Arterial puncture
Local anesthesia
Eutectic mixture
Lidocaïne/prilocaïne cream (5%)
Placebo
Pain Intensity Scale
Numerical Rating Scale
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2013-10-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: interest of local anesthesia (lidocaïne/prilocaïne)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Monocentric study
Study officials:
affiliation: Hôpital Morvan, CHRU de Brest
name: Francis COUTURAUD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.