- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07603323
Comparison of Analgesic Effects of ACB Versus ACB Combined With BiFeS Block in Meniscopathy Surgery
Comparison of Analgesic Effects of Adductor Canal Block Versus Adductor Canal Block Combined With BiFeS (Biceps Femoris Short Head) Block in Meniscopathy Surgery
Meniscopathy surgeries are commonly associated with moderate postoperative pain, particularly during early mobilization and rehabilitation. Inadequate postoperative analgesia may negatively affect functional recovery, delay ambulation, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing arthroscopic knee procedures.
Adductor canal block (ACB) is a widely used regional anesthesia technique that provides effective analgesia while largely preserving quadriceps muscle strength. However, its limited effect on posterior knee capsule innervation may result in insufficient control of posterior knee pain. Recently, the biceps femoris short head (BiFeS) block has been described as a novel motor-sparing fascial plane block targeting the posterolateral knee capsule and may provide additional analgesic benefit when combined with ACB.
In this study, it was aimed to compare the postoperative analgesic efficacy of adductor canal block alone and adductor canal block combined with BiFeS block in patients undergoing surgery for meniscopathy.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Atakan Sezgi
- Número de teléfono: 00905323327000
- Correo electrónico: kansezgi@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Musa Zengin
- Número de teléfono: 00905307716235
- Correo electrónico: musazengin@gmail.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Reclutamiento
- Ankara Etlik City Hospital
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Contacto:
- Musa Zengin, Associate Professor
- Número de teléfono: 00905307716235
- Correo electrónico: musazengin@gmail.com
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Contacto:
- Atakan Sezgi, M.D.
- Número de teléfono: 00905323327000
- Correo electrónico: kansezgi@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:
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Exclusion Criteria:
- Patients under 18 and over 65 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Adductor Canal Block Group
After the linear ultrasound probe is placed transversely over the mid-thigh on the side of surgery, the sartorius muscle, femoral artery, vastus medialis muscle, and adductor canal will be identified.
The probe will be adjusted to obtain an optimal short-axis view of the femoral artery beneath the sartorius muscle.
A block needle will then be advanced using an in-plane technique toward the adductor canal.
After negative aspiration, 10 ml of 0.25% bupivacaine will be injected into the fascial plane adjacent to the femoral artery within the adductor canal.
Proper spread of the local anesthetic around the femoral artery and beneath the sartorius muscle will be confirmed by ultrasound imaging.
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Adductor canal block will be performed on the patients using 10 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
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Comparador activo: Adductor Canal Block + BiFeS (Biceps Femoris Short Head) Block Group
First, 10 ml of 0.25% bupivacaine will be injected into the adductor canal, and proper spread of the local anesthetic around the femoral artery and beneath the sartorius muscle will be confirmed by ultrasound imaging.
Subsequently, the biceps femoris short head block will be performed under ultrasound guidance on the same side.
The ultrasound probe will be positioned to identify the short head of the biceps femoris muscle and the lateral femoral cortex at the distal thigh/supracondylar region.
A block needle will be advanced using an in-plane technique toward the fascial plane between the short head of the biceps femoris muscle and the lateral femoral cortex.
After negative aspiration, 20 ml of 0.25% bupivacaine will be injected into this plane.
Adequate spread of the local anesthetic along the interface between the biceps femoris short head and the femur will be confirmed by ultrasound imaging.
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In the adductor canal block + BiFeS block group, adductor canal block will be performed using 10 ml of 0.25% bupivacaine, followed by BiFeS block using 20 ml of 0.25% bupivacaine under ultrasound guidance, with a total local anesthetic volume of 30 ml. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
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Comparador activo: Control Group
Participants in the control group will not receive any regional block intervention.
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In the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain Scores
Periodo de tiempo: On the operation day
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Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain).
Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
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On the operation day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Postoperative Morphine Consumption During the First 24 Hours After Surgery
Periodo de tiempo: On the operation day
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Total Postoperative Morphine Consumption During the First 24 Hours After Surgery
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On the operation day
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Agnosia
- Técnicas de investigación
- Diseño de investigación epidemiológica
- Métodos epidemiológicos
- Diseño de la investigación
- Métodos
- Grupos de control
Otros números de identificación del estudio
- AEŞH-EK-2026-071
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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