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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Koege, Dinamarca, 4600
- Department of Anesthesiology Koege Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
Otros nombres:
20 ml Ropivacaine 5mg/ml
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Hipnóticos y sedantes
- Anestésicos Locales
- Dexmedetomidina
- Ropivacaína
Otros números de identificación del estudio
- SM2-JH-14
- 2014-005651-89 (Número EudraCT)
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