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ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy

8 de junio de 2026 actualizado por: Beyhan Guner, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Prospective Comparison of Postoperative Analgesic Effects of ESP Block and EXORA Block in Nephrectomy Cases

The goal of this observational study is to learn about the effects of two pain control techniques used after laparoscopic nephrectomy (kidney removal surgery) in adults. The study will compare Erector Spinae Plane (ESP) block and External Oblique Rectus Abdominis (EXORA) block, which are both used as part of routine medical care to help control pain after surgery.

The main questions it aims to answer are:

Do ESP block and EXORA block differ in how well they control pain after surgery? Do ESP block and EXORA block differ in their effects on recovery quality and the need for additional pain medication?

Researchers will compare participants who receive ESP block with participants who receive EXORA block as part of routine clinical care.

Participants will:

Undergo laparoscopic nephrectomy according to routine clinical practice. Receive either ESP block or EXORA block based on the treating anesthesiologist's usual clinical preference.

Complete a recovery questionnaire before surgery and 24 hours after surgery. Have pain scores, use of additional pain medication, nausea and vomiting, and other routine postoperative measurements recorded during the first 24 hours after surgery.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

In routine practice at our institution, anesthesia clinicians performing laparoscopic nephrectomy administer either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either ESP or EXORA block will be included and evaluated observationally. Block types other than these two will not be included.

All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, and administering the QoR-15 questionnaire preoperatively and at postoperative 24 hours.

Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied. Anesthesia induction is performed using standard agents and general anesthesia is maintained according to the clinician's routine practice.

For postoperative analgesia, all patients routinely receive intravenous paracetamol 1 g every 8 hours. Rescue analgesia consists of intravenous tramadol 1 mg/kg when NRS ≥4. After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9.

Postoperative nausea and vomiting (PONV) are assessed using a verbal descriptive scale (0-4) and intravenous ondansetron 4 mg is administered for PONV ≥2.

Tipo de estudio

De observación

Inscripción (Estimado)

84

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

  • Nombre: Şeyma Nur Güner Zengin, MD
  • Número de teléfono: +90 212 414 71 71
  • Correo electrónico: snurguner@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Nalan Saygı Emir, MD, Associate Professor
  • Número de teléfono: +90 212 414 71 71
  • Correo electrónico: nasaemir@hotmail.com

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turquía (Türkiye), 34147
        • Reclutamiento
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adult patients aged 18-80 years undergoing laparoscopic nephrectomy and receiving either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block according to routine clinical practice.

Descripción

Inclusion Criteria:

  • Age between 18 and 80 years
  • Patients scheduled for laparoscopic nephrectomy
  • Patients for whom Erector Spinae Plane (ESP) block or External Oblique Rectus Abdominis (EXORA) block has been selected by the treating clinician
  • ASA physical status I-III

Exclusion Criteria:

  • No regional block performed in routine clinical practice
  • Body mass index (BMI) greater than 35 kg/m²
  • History of opioid dependence
  • Alcohol or other substance dependence
  • Psychiatric disease, mental retardation, dementia, or any condition impairing pain perception or pain assessment

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Group E
Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.
Procedimiento: Erector Spinae Plane Block
An ultrasound-guided Erector Spinae Plane (ESP) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is placed over the T10 transverse process on the surgical side. The needle is advanced into the fascial plane between the erector spinae muscle and the transverse process. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
Otros nombres:
  • ESP BLock
Group X
Participants undergoing laparoscopic nephrectomy who receive External Oblique Rectus Abdominis (EXORA) block as part of routine clinical care.
Procedimiento: External Oblique Rectus Abdominis Block
An ultrasound-guided External Oblique Rectus Abdominis (EXORA) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned in the parasternal sagittal plane lateral to the xiphoid process at the level of the 8th costal cartilage on the surgical side. The needle is advanced into the fascial plane between the rectus abdominis and external oblique muscles. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
Otros nombres:
  • EXORA Block

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Score (NRS)
Periodo de tiempo: Postoperative 1, 6, 12, and 24 hours
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 6, 12, and 24 hours after surgery and will be compared between Group E and Group X. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Postoperative 1, 6, 12, and 24 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rescue Analgesic Requirement
Periodo de tiempo: First 24 hours after surgery
The requirement for rescue analgesia and the total amount of postoperative tramadol consumption during the first 24 hours will be recorded and compared between Group E and Group X.
First 24 hours after surgery
Quality of Recovery (QoR-15 Score)
Periodo de tiempo: Preoperative baseline and postoperative 24th hour
Quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. Scores will be compared between Group E and Group X. The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Preoperative baseline and postoperative 24th hour

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Nausea and Vomiting (PONV) Score
Periodo de tiempo: Postoperative 1, 6, 12, and 24 hours
Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes). Scores will be compared between Group E and Group X.
Postoperative 1, 6, 12, and 24 hours

Colaboradores e Investigadores

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

Patrocinador

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

1 de junio de 2026

Finalización primaria (Estimado)

1 de agosto de 2029

Finalización del estudio (Estimado)

1 de agosto de 2029

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

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

8 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BEAH 2026/191

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared because the study protocol does not include a data-sharing plan and the collected data will be used only for the purposes of the current study.

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. .

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