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Local Anesthesia Before Arterial Puncture for Blood Gas Analysis (GAEL)

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ClinicalTrials.gov Identifier: NCT01964248
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Indication of Blood Gas Analysis by Radial Artery Blood Sampling Drug: Placebo Drug: lidocaïne/prilocaïne 5% Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study
Study Start Date : December 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Drug: lidocaïne/prilocaïne 5%
Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample
Placebo Comparator: Placebo
  • Single dose: 2 grams (one tube of cream)
  • Cream applied 2 hours before blood sample
Drug: Placebo
Placebo cream applied 2 hours before blood sample
Other Name: Application placebo cream 2 hours before blood sample



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964248


Locations
France
Monocentric study
Brest, France
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Francis COUTURAUD, Professor Hôpital Morvan, CHRU de Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01964248     History of Changes
Other Study ID Numbers: RB 12.011 (GAEL)
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by University Hospital, Brest:
Blood gas analysis
Arterial puncture
Local anesthesia
Eutectic mixture
Lidocaïne/prilocaïne cream (5%)
Placebo
Pain Intensity Scale
Numerical Rating Scale

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Prilocaine
EMLA
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined