- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00657358
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
11 aprile 2017 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
22
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama at Birmingham
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
19 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Ischemic Pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Michael Froelich, MD, University of Alabama at Birmingham
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2008
Completamento primario (Effettivo)
1 gennaio 2012
Completamento dello studio (Effettivo)
1 gennaio 2012
Date di iscrizione allo studio
Primo inviato
9 aprile 2008
Primo inviato che soddisfa i criteri di controllo qualità
11 aprile 2008
Primo Inserito (Stima)
14 aprile 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 aprile 2017
Ultimo verificato
1 aprile 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antiaritmici
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Agenti del sistema sensoriale
- Anestetici
- Modulatori di trasporto a membrana
- Anestetici, Locali
- Bloccanti dei canali del sodio voltaggio-dipendenti
- Bloccanti dei canali del sodio
- Lidocaina
Altri numeri di identificazione dello studio
- F061204013
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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