Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
Perineural Dexmedetomidine vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Wielkopolska
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Poznan, Wielkopolska, Polonia, 61-545
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
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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:
- children scheduled for foot/ankle surgery
- body weight > 5kg
Exclusion Criteria:
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
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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Comparador de placebos: Sham Block
0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
Otros nombres:
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Comparador activo: Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
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Comparador activo: Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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time to the first need of opiate following the procedure
Periodo de tiempo: within 48 hours
|
Time after surgery when the patient needs opiate for the first time |
within 48 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 4 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
4 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 6 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
6 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 8 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
8 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 12 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
12 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 16 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
16 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 20 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
20 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 24 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
24 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 36 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
36 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Periodo de tiempo: 48 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
48 hours
|
|
Neutrophil-to-lymphocyte ratio
Periodo de tiempo: 24 hours after surgery
|
Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample. |
24 hours after surgery
|
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Platelet-to-lymphocyte ratio
Periodo de tiempo: 48 hours after surgery
|
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
48 hours after surgery
|
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Platelet-to-lymphocyte ratio
Periodo de tiempo: 24 hours after surgery
|
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
24 hours after surgery
|
|
Time to mobilization
Periodo de tiempo: within 48 hours
|
Time after surgery when the patient moves the toe for the first time |
within 48 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Tomasz Kotwicki, Prof dr hab, Poznan University of Medical Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Heridas y Lesiones
- Procesos Patológicos
- Lesiones en las piernas
- Enfermedades de la piel
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Lesiones de tobillo
- Enfermedad
- Enfermedades de los pies
- Lesiones en los pies
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Compuestos policíclicos
- Imidazoles
- Químicos inorgánicos
- Compuestos de cloro
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Esparrazadienetrioles
- Compuestos de sodio
- Cloruros
- Ácido clorhídrico
- Dexametasona
- Dexmedetomidina
- Cloruro de sodio
Otros números de identificación del estudio
- 18/2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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