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- Essai clinique NCT00657358
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
11 avril 2017 mis à jour par: Michael Froelich, University of Alabama at Birmingham
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers (Carl Koller Grant) (The Effect of Intravenous Lidocaine on Allodynia)
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
Aperçu de l'étude
Description détaillée
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects.
Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.
Type d'étude
Interventionnel
Inscription (Réel)
22
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
19 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy Adult Volunteers, age >19 years
Exclusion Criteria:
- History of Substance Abuse
- Coronary Artery Disease (CAD): unstable
- Congestive Heart Failure (CHF): unstable
- Heart Arrhythmia: symptomatic
- Chronic Obstructive Pulmonary Disease (COPD)
- Lidocaine Allergy
- Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
- Presence of Contraindications for MRI
- Presence of electronically, magnetically, and mechanically activated implants
- Electronically, magnetically, and mechanically activated implants
- Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
- Cardiac pacemakers
- Metallic splinters in the eye
- Ferromagnetic haemostatic clips in the central nervous system (CNS)
- Claustrophobia
- Pregnancy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Lidocaine
Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
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Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Ischemic Pain
Délai: baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant's mean arterial pressure.
Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength.
Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.
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baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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Electrical Pain
Délai: Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England).
Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments.
Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo).
For each measure, the average of three trials was computed for use in subsequent analyses.
Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design.
The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable
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Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Heat Pain
Délai: baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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The thermal procedure involved a baseline assessment of heat pain threshold and tolerance.
Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator.
Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s.
The 3 × 3 cm contact probe was applied to the right forearm.
The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable
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baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Cold Pain
Délai: baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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The participant's foot was immersed up to the ankle into a container filled with ice water of 3°C.
Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance).
The length of time was recorded in seconds.
This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests.
The range was 0 seconds to 120 seconds
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baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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Tactile Sensation
Délai: baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel.
The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 mg).
A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle.
The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits.
This assessment was to evaluate whether participants were able to feel the touch of the needle.
The participant's arm was placed on a tray table.
A linen sheet was suspended in-between two IV poles in such a fashion that the subject's view of his/her hand was blocked.
Normal values are between 0.21mg and 5mg.
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baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michael Froelich, MD, University of Alabama at Birmingham
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2008
Achèvement primaire (Réel)
1 janvier 2012
Achèvement de l'étude (Réel)
1 janvier 2012
Dates d'inscription aux études
Première soumission
9 avril 2008
Première soumission répondant aux critères de contrôle qualité
11 avril 2008
Première publication (Estimation)
14 avril 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-arythmie
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Anesthésiques
- Modulateurs de transport membranaire
- Anesthésiques locaux
- Bloqueurs de canaux sodiques voltage-dépendants
- Bloqueurs des canaux sodiques
- Lidocaïne
Autres numéros d'identification d'étude
- F061204013
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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