Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?
Does Perineural Dexmedetomidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background:
Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.
Method:
On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded to volunteer and investigator.
The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Koege, Dinamarca, 4600
- Department of Anesthesiology Koege Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Exclusion Criteria:
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
- Alcohol or drug abuse
- Daily intake of opioids or steroids last 4 weeks
- Daily intake of any analgesics last 48 hours Heart block Sick sinus node.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Ropivacaine + Dexmedetomidine
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml
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100 ug dexmedetomidine added to the ropivacaine nerveblock
Outros nomes:
20 ml Ropivacaine 5mg/ml
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Comparador de Placebo: Ropivacaine + Placebo
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline
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20 ml Ropivacaine 5mg/ml
Placebo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
Prazo: 0-36 hours
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Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0) Time for sleep will be provided.
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0-36 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
Prazo: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Prazo: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.Time for sleep will be provided.
Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.
A Linear 100mm visual analogue scale (VAS) will be used.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold
Prazo: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Time for sleep will be provided
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
Prazo: 0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.
Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
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0-36 hours
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Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.
Prazo: 0-36 hours
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Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values.
Time for sleep will be provided.
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0-36 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jakob H Andersen, MD, Department of Anesthesiology Koege Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Anestésicos
- Analgésicos, Não Narcóticos
- Agonistas de Receptores Alfa-2 Adrenérgicos
- Alfa-Agonistas Adrenérgicos
- Agonistas Adrenérgicos
- Hipnóticos e Sedativos
- Anestésicos Locais
- Dexmedetomidina
- Ropivacaína
Outros números de identificação do estudo
- SM2-JH-14
- 2014-005651-89 (Número EudraCT)
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