Comparison of Analgesic Efficacy and Impact on Motor Function in Knee Replacement Surgery: 0.1% Naropeine Tri-block Versus 0.5% Naropeine iPACK Saphenous Block - A Prospective Randomised Trial (ProBlocs)
Over the last two decades, perioperative analgesia has evolved. Spinal and epidural anaesthesia, once common, have been gradually phased out due to their side effects. The femoral block combined with the sciatic block, possibly with a perineural catheter, is now the gold standard for ensuring prolonged, high-quality analgesia. However, these blocks can cause muscle weakness in the quadriceps, limiting patients' functional recovery.
To optimise functional rehabilitation, recent techniques favour more distal and selective blocks, such as the adductor canal (saphenous) block and the iPACK, which allow effective anaesthesia to be maintained whilst preserving motor function. However, these blocks do not always guarantee complete analgesia and may require additional blocks.
The hypothesis of the current study is based on the idea that a proximal block targeting the femoral, obturator and sciatic nerves, administered with a low concentration of naropeine (0.1%), could provide more effective analgesia than a 0.5% saphenous iPACK block, whilst preserving motor function The originality of our approach in the current study lies in the use of dissociative proximal blocks performed with low concentrations of local anaesthetics, aimed at effectively covering the innervation of the knee whilst preserving motor function.
The expected outcomes of this research are to optimise analgesic management for patients undergoing functional orthopaedic knee surgery, to promote early postoperative walking rehabilitation, to reduce the risk of chronic pain following knee arthroplasty, and to provide evidence to guide anaesthetic and post-surgical rehabilitation practices
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Emilie ELLIES DROUAUD
- Número de teléfono: +33 (0)679324918
- Correo electrónico: elliese64@gmail.com
Ubicaciones de estudio
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Paris, Francia, 75016
- Clinique Jouvenet
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Contacto:
- Dr Emilie ELLIES DROUAUD
- Número de teléfono: +33 (0)679324918
- Correo electrónico: elliese64@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age > 18 years;
- Patients scheduled for total knee replacement (TKR);
- ASA (American Society of Anesthesiologists) class 1 to 3;
- Patient who is able to understand the information relating to the study, read the information leaflet and agree to sign the informed consent form;
- Enrolment iin the French healthcare system.
Exclusion Criteria:
- Patients with an ASA score > 3;
- Patients with a chronic pain condition requiring regular prescription pain relief, such as osteoarthritis, fibromyalgia, neuropathic pain or rheumatoid arthritis;
- Patients with a major anxiety disorder (APAIS score);
- Patients with a history of algodystrophy;
- Pregnant or breastfeeding women;
- History or evidence of any other clinically significant disorder, condition or disease which, in the investigator's opinion, would pose a risk to patient safety or interfere with the assessment, procedures or completion of the study;
- Participation in any other clinical trial during the duration of the study;
- Patients under guardianship or curatorship or subject to deprivation of liberty.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental group (tri-block)
Anaesthesia of femoral block, obturator block and popliteal sciatic block performed using 0.1% naropeine, combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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Injection of 0.1% naropeine for a femoral, obturator and sciatic block (Tri-block technique), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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Comparador activo: Control Group (iPACK saphène)
Anaesthesia of iPACK block and saphenous block performed using 0.5% naropine, also combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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Injection of 0.5% naropeine for an iPACK and saphenous nerve block (iPACK saphenous arm), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Total morphine consumption in the postoperative period at 72 hours during the hospital stay
Periodo de tiempo: from knee surgery (enrollment) to 3 days post-surgery
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from knee surgery (enrollment) to 3 days post-surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- COS-RGDS-2024-12-033
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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