The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty. (HOBSALIplus)
The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of two treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
- B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age> 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- ASA 1-3
Exclusion Criteria:
- Patients who can not cooperate with the investigation
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients receiving glucocorticoid daily
- Patients with a treatment-dependent diabetes mellitus
- Patients with known neuropathy in the lower limbs
- Allergy to those used in the study drugs
- Alcohol and / or drug abuse - the investigator's opinion
- Patients who can not tolerate NSAIDs
- Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Combined nerve block
Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone
|
Otros nombres:
|
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Comparador activo: Local infiltrationanalgesia
Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone
|
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Opioid consumption
Periodo de tiempo: 0 - 20 hours postoperatively
|
0 - 20 hours postoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Opioid consumption
Periodo de tiempo: 0 - 24 hours postoperatively
|
0 - 24 hours postoperatively
|
|
|
Pain Score by passive flexion of the knee joint from 0-90 degrees.
Periodo de tiempo: At timepoint 2 , 6, 20 and 24 hours postoperatively
|
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
|
At timepoint 2 , 6, 20 and 24 hours postoperatively
|
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Pain score at rest
Periodo de tiempo: At timepoint 2 , 6, 20 and 24 hours postoperatively
|
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
The highest score since last score recorded.
|
At timepoint 2 , 6, 20 and 24 hours postoperatively
|
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Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
Periodo de tiempo: 0-24 hours postoperatively
|
Recorded at PCA(patient-controlled-analgesia) pump
|
0-24 hours postoperatively
|
|
Nausea Score
Periodo de tiempo: At timepoint 2, 6, 20, 24 hours postoperatively
|
NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea.
The highest score since last score recorded.
|
At timepoint 2, 6, 20, 24 hours postoperatively
|
|
Number of vomiting
Periodo de tiempo: 0- 20 hours and 0-24 hours postoperatively
|
0- 20 hours and 0-24 hours postoperatively
|
|
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Consumption of Ondansetron
Periodo de tiempo: 0-20 hours and 0-24 hours
|
0-20 hours and 0-24 hours
|
|
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Reporting of dizziness Recording whether the dizziness is preventing mobilization.
Periodo de tiempo: at timepoint 2, 6, 20 and 24 hours postoperatively.
|
Recording whether the dizziness is preventing
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at timepoint 2, 6, 20 and 24 hours postoperatively.
|
|
Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
Periodo de tiempo: 0-24 hours postoperatively
|
The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.
|
0-24 hours postoperatively
|
|
Discharge time from the hospital
Periodo de tiempo: maximum 60 hour postoperatively.
|
maximum 60 hour postoperatively.
|
|
|
Preoperatively isometric tests of muscle strength in the hip adductors.
Periodo de tiempo: pre and 30 minutes after block placement
|
Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades.
The patient performed 4-10 measurements with a 30 second break in between each measurement.
The difference between the highest value for the test before and after nerve block is calculated.
|
pre and 30 minutes after block placement
|
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Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
Periodo de tiempo: 0-24 hours posteratively
|
0-24 hours posteratively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Charlotte Runge, MD, Regionalhospital Silkeborg
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la ciclooxigenasa
- Agentes antineoplásicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Anestésicos Locales
- Dexametasona
- Ketorolaco
- Ropivacaína
Otros números de identificación del estudio
- 2014-003343-35
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