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The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers

11 de abril de 2017 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

22

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama at Birmingham

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: 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.
Outros nomes:
  • Anestesia local

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ischemic Pain
Prazo: baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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.
baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
Electrical Pain
Prazo: Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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
Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
Heat Pain
Prazo: baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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
baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
Cold Pain
Prazo: baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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
baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
Tactile Sensation
Prazo: baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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.
baseline, during 20 minute infusion, and 30 minutes after completion of infusion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Alabama at Birmingham

Colaboradores

American Society of Regional Anesthesia

Investigadores

  • Investigador principal: Michael Froelich, MD, University of Alabama at Birmingham

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2008

Conclusão Primária (Real)

1 de janeiro de 2012

Conclusão do estudo (Real)

1 de janeiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

9 de abril de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de abril de 2008

Primeira postagem (Estimativa)

14 de abril de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de maio de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de abril de 2017

Última verificação

1 de abril de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • F061204013

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