- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07594197
Parasacral Ischial Plane Block in Lower Extremity Surgery
Evaluation of Sensory and Motor Blockade of Ultrasound-Guided Parasacral Ischial Plane Block in Lower Extremity Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sympatholysis resulting from central neuraxial block or general anesthesia in lower extremity surgeries may lead to adverse hemodynamic changes and increased perioperative mortality, particularly in high-risk patients. In such patients, lower extremity procedures can be successfully performed solely under sciatic and femoral nerve blocks. Depending on the surgical indication, the sciatic nerve block may be utilized alone or in combination with a lumbar plexus or femoral nerve block.A novel ultrasound-guided (USG) fascial plane approach targeting the sacral plexus, termed the Parasacral Ischial Plane (PIP) block, has been successfully investigated in a limited number of patients. The sacral plexus is located within a fascial plane formed by the pelvic fascia anteriorly, the sacrum medially, the piriformis and gluteus maximus muscles posteriorly, and the ischium bone laterally. The piriformis muscle has no attachment to the ischium; instead, it attaches laterally to the greater trochanter. A fascial plane exists between the piriformis muscle and the ischium, which extends directly to the sacral plexus.
Venkataraju et al. stated that during the demonstration of the PIP block, the needle should be directed and positioned toward the posteromedial surface of the ischium. Following bony contact, the injectate was administered, and its spread was observed beneath the piriformis muscle toward the sacral plexus (SP). This method is considered to be technically more straightforward and carries a lower risk profile.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: NURULLAH DAMLA
- Número de teléfono: +905075482122
- Correo electrónico: nurullahdamla@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Korgün Ökmen, professor
- Número de teléfono: +905057081021
- Correo electrónico: korgunokmen@gmail.com
Ubicaciones de estudio
-
-
Yildirim
-
Bursa, Yildirim, Turquía (Türkiye), 16300
- Bursa High Specialization Training and Research Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Ages 18-80
- ASA I-III
- Patients operated on under regional anesthesia
- Patients who provided written informed consent
- Patients scheduled for elective lower extremity surgery -
Exclusion Criteria:
- Patients with a history of allergy to local anesthetic drugs
- Patients with coagulation disorders
- Patients with BMI > 40 kg/m²
- Presence of infection at the block application site
- Chronic pain syndrome (chronic opioid use)
- Pregnant women
- Patients who cannot be communicated with
- Patients requiring emergency surgery -
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Parasacral Ischial Plan Block
A novel ultrasound-guided fascial plane approach to the sacral plexus, called the Parasacral-Ischial Plane (PIP) block, has been successfully studied in a small number of patients. The sacral plexus is located within a fascial plane formed by the pelvic fascia anteriorly, the sacrum medially, the piriformis and gluteus maximus muscles posteriorly, and the ischium laterally. The piriformis muscle has no attachment to the ischium and attaches to the greater trochanter laterally. A fascial plane exists between the piriformis muscle and the ischium; this fascial plane extends to the sacral plexus. Venkataraju et al. stated that in a PIP block demonstration, the needle should be directed and placed towards the posteromedial surface of the ischium. After bone contact, medication was injected, and it was observed that the medication spread from under the piriformis muscle towards the sacral plexus. This method is considered easier and less risky. |
The sacral plexus is located within a fascial plane formed by the pelvic fascia anteriorly, the sacrum medially, the piriformis and gluteus maximus muscles posteriorly, and the ischium laterally. The piriformis muscle has no attachment to the ischium and attaches to the greater trochanter laterally. A fascial plane exists between the piriformis muscle and the ischium; this fascial plane extends to the sacral plexus. Venkataraju et al. stated that in PIP block demonstrations, the needle should be directed and placed towards the posteromedial surface of the ischium. After bone contact, the medication was injected, and it was observed that the medication spread from under the piriformis muscle towards the sacral plexus. |
|
Comparador activo: Sacral plexus block
This block, defined by the parasacral approach, targets the exit point of the plexus at the level of the foramen ischiadicum majus.
Unlike distal sciatic blocks, blocking at this level includes the posterior cutaneous femoral nerve, superior/inferior gluteal nerve, and pudendal nerve, along with the ischial nerve.
In current practice, ultrasonography (USG) has become the "gold standard"; visualizing the neural structures deep to the piriformis muscle by placing the probe between the lateral sacrum and the iliac wing increases the success rate while minimizing the risk of complications.
|
This block, defined by the parasacral approach, targets the exit point of the plexus at the level of the foramen ischiadicum majus.
Unlike distal sciatic blocks, blocking at this level includes the posterior cutaneous femoral nerve, superior/inferior gluteal nerve, and pudendal nerve, along with the ischial nerve.
In current practice, ultrasonography (USG) has become the "gold standard"; visualizing the neural structures deep to the piriformis muscle by placing the probe between the lateral sacrum and the iliac wing increases the success rate while minimizing the risk of complications.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sensory and motor block onset time
Periodo de tiempo: 1 hour
|
This approach is based on the volume-dependent spread of local anesthetic into the plane between the sacral plexus and the deep pelvic muscle fascia; sensory blockade begins proximally to distally within 10-20 minutes, while motor blockade usually develops later and gradually around 20-30 minutes.
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Numerical Rating Scale (NRS)
Periodo de tiempo: 1 Day
|
Pain control is a one-dimensional measurement tool, usually ranging from 0 to 10, used to subjectively assess a patient's pain intensity.
In academic literature, this scale, expressed with integers from 0 (no pain) to 10 (the most severe pain imaginable), is considered a fundamental parameter for pain monitoring in clinical research and perioperative processes due to its high validity, ease of application, and flexibility in verbal or written form.
|
1 Day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.
- Zhao J, Huang Y, Fu M, Tao F. Ultrasound-guided suprainguinal fascia iliaca block combined with a sacral plexus block for lower extremity surgery: A case report. Medicine (Baltimore). 2020 Aug 28;99(35):e21921. doi: 10.1097/MD.0000000000021921.
- Arjun BK, Prijith RS, Sreeraghu GM, Narendrababu MC. Ultrasound-guided popliteal sciatic and adductor canal block for below-knee surgeries in high-risk patients. Indian J Anaesth. 2019 Aug;63(8):635-639. doi: 10.4103/ija.IJA_296_19.
- Chia N, Low TC, Poon KH. Peripheral nerve blocks for lower limb surgery--a choice anaesthetic technique for patients with a recent myocardial infarction? Singapore Med J. 2002 Nov;43(11):583-6.
- Bech B, Melchiors J, Borglum J, Jensen K. The successful use of peripheral nerve blocks for femoral amputation. Acta Anaesthesiol Scand. 2009 Feb;53(2):257-60. doi: 10.1111/j.1399-6576.2008.01859.x.
- Venkataraju A, Narayanan M, Phillips S. Parasacral ischial plane (PIP) block: An easy approach to sacral plexus. J Clin Anesth. 2020 Feb;59:103-105. doi: 10.1016/j.jclinane.2019.06.030. Epub 2019 Jul 16. No abstract available.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BursaYIERH-AR-ND-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .