Local Anesthesia Before Arterial Puncture for Blood Gas Analysis

Phase 3

Completed

• Conditions: Indication of Blood Gas Analysis by Radial Artery Blood Sampling
• Interventions: Drug: lidocaïne/prilocaïne 5%; Drug: Placebo

• Registration Number: NCT01964248
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaïne/prilocaïne	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	* Single dose: 2 grams (one tube of cream) * Cream applied 2 hours before blood sample

Primary Outcome Measures

Name	Time	Method
interest of local anesthesia (lidocaïne/prilocaïne)	1 hour	Determine the interest of local anesthesia with association of lidocaïne/prilocaïne before arteriel puncture for gas analysis

Trial Locations

Locations (1)

Monocentric study; 🇫🇷 Brest, France