Trial record 3 of 2554 for:    Open Studies | "Blood"

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

This study is currently recruiting participants.
Verified October 2013 by University Hospital, Brest
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01964248
First received: July 25, 2013
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • interest of local anesthesia (lidocaïne/prilocaïne) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Determine the interest of local anesthesia with association of lidocaïne/prilocaïne before arteriel puncture for gas analysis


Estimated Enrollment: 136
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01964248

Contacts
Contact: Francis COUTURAUD, Professor +33 2 98 34 73 47 francis.couturaud@chu-brest.fr

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

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01964248     History of Changes
Other Study ID Numbers: RB 12.011 (GAEL)
Study First Received: July 25, 2013
Last Updated: October 15, 2013
Health Authority: France : ANSM - Agence Nationale de Sécutité du Médicament et des produits de santé (waiting for ANSM authorization)

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
Prilocaine
Lidocaine
EMLA
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on April 16, 2014