Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Comparative Study Between Ultrasound Guided Paravertebral Plane Block and Erector Spinae Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy

22 de mayo de 2026 actualizado por: Ain Shams University
The intent of this study is to compare the efficacy of the erector spinae plane block (ESPB) and paravertebral plane block in reducing postoperative opioid consumption and pain in patients with total abdominal hysterectomy.

Descripción general del estudio

Descripción detallada

The intent of this study is to compare the efficacy of the erector spinae plane block (ESPB) and paravertebral plane block in reducing postoperative opioid consumption and pain in patients with total abdominal hysterectomy. All patients will be assessed preoperatively by history taking, full physical examination, and laboratory evaluation CBC, coagulation, kidney and liver function. inform the patient about VAS score, On arrival of the patients to the operating room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. the vital signs parameters including mean arterial pressure (MAP), heart rate (HR), respiratory (RR) and SpO2 will be measured every 5 minutes recorded at base line and every 30 minutes till end of surgery. Intravenous (IV) line will be inserted and IV fluids 500ml normal saline will be started.

In the induction of general anesthesia, the patient will receive intravenous fentanyl (2 μg /kg) and propofol (2 mg/kg). atracurium (0.5 mg/kg) then tracheal intubation and the mechanical ventilator will be employed to maintain the end-tidal CO2 between 30 and 35 mmHg. Depending on the requirements of the patient, both inhaled (Sevoflurane) and intravenous (IV) atracurium will be utilized for anesthetic maintenance.

Preparation of local anesthesia 20 ml bupivacaine 0.25% for the block for each side without exceeding the toxic dose 2mg/kg [. then the block will be performed on the lateral position.

Both blocks will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath.

Group 1(Paravertebral Plane Block) (24 Patients); The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.

Group 2 (Erector Spinae Plane Block) (24 Patients); The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.

Monitor HR & MAP and if any increase more than 20% from the baseline value will receive fentanyl 50 µg IV incremental and recording total dose of fentanyl consumption

All patients receive:

Dexamethasone 8 mg IV and Ondansetron 4 mg IV

Reversal:

Neostigmine 0.05 mg/kg and Atropine 0.02 mg/kg Post-operative settings: At the end of the surgery, the patient will be kept under observation postoperatively in the recovery room for 30 min to monitor vital signs (mean arterial pressure, heart rate, respiratory rate) and the conscious level then will be discharged to the ward to be followed.

Postoperative pain: The assessment of postoperative pain will be evaluated postoperatively in the recovery room on arrival (zero time), after 30 minutes, 2,4,6,8,12,16,20, and 24 hours postoperatively in the surgical ward with visual analogue scale (1-10).

All patients will receive paracetamol 1 gm every 8 hrs. At score of3 or more, rescue analgesic 3 mg morphine iv Will be given. Total analgesic dose of morphine during first 24 hours will be recorded.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

48

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Abbasia
      • Cairo, Abbasia, Egipto, 00202
        • Ain Shams

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • ASA I and ASA II patients.
  • Female, 30-60 years of age.
  • Scheduled for total abdominal hysterectomy.

Exclusion criteria:

  • Patient refusal of procedure or participation in the study.
  • Opioid or analgesic abuse.
  • Known allergy to study drug.
  • Any contraindication of regional anesthesia including:
  • Local infection at the site of puncture.
  • Having history of hematological disorders, including coagulation abnormality.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Paravertebral Plane Block
the group will receive paravertebral plane block, The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.
The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.
20 ml of 0.25% bupivacaine will be injected
Comparador activo: Erector Spinea Plane Block
the group will receive Erector Spinae Plane Block; The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.
20 ml of 0.25% bupivacaine will be injected
The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
total morphine consumption
Periodo de tiempo: from the end of surgey to 24 hrs post operative
Postoperative total morphine requirements in the first 24 hours after surgery.
from the end of surgey to 24 hrs post operative

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

10 de mayo de 2026

Finalización primaria (Estimado)

15 de enero de 2027

Finalización del estudio (Estimado)

20 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FMASU MD354/2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir