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Predictors of Epidural Depth in Percutaneous Nephrolithotomy and Model Development

13 de julio de 2026 actualizado por: Hongbo Zheng, Tongji Hospital

Analysis of Factors Influencing Epidural Depth in Patients Undergoing Percutaneous Nephrolithotomy and Development of a Predictive Model

Accurate estimation of epidural depth is critical for safe epidural anesthesia during percutaneous nephrolithotomy (PCNL). Although various imaging modalities can predict epidural depth, they increase healthcare burden and are not always feasible in emergency or bedside settings. Identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority. However, systematic investigations specifically targeting the Chinese population remain scarce. This retrospective study aims to identify independent factors influencing epidural depth in PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of kidney stones larger than 2 cm and is established as the gold standard for the management of complex renal calculi. This procedure may be performed under either general anesthesia or regional anesthesia, including epidural or spinal anesthesia. Accumulating meta-analyses have demonstrated that, compared with general anesthesia, regional anesthesia is associated with reduced postoperative pain scores and lower total hospital costs, without compromising the stone-free rate. Furthermore, in awake patients undergoing regional anesthesia, respiratory movements may generate a so-called "respiratory-synchronous stone fragmentation effect," which facilitates the expulsion of stone debris.

Successful epidural anesthesia relies critically on accurate identification of the epidural space and precise control of puncture depth. Insufficient puncture depth may result in improper catheter placement and subsequent block failure, whereas excessive puncture depth increases the risk of dural puncture, leading to cerebrospinal fluid leakage and post-dural puncture headache. In severe cases, inadvertent injection of a large dose of local anesthetics into the subarachnoid space can cause life-threatening cardiovascular and respiratory depression. Therefore, preprocedural estimation of the skin-to-epidural space distance is of considerable clinical importance.

Although racial differences in epidural depth have been reported, systematic investigations specifically targeting the Chinese population remain scarce. Various imaging modalities, including computed tomography, magnetic resonance imaging, and ultrasound, can be used to predict epidural depth. However, these examinations increase healthcare burden and are not always feasible in emergency or bedside settings. Consequently, identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority.

In this context, the present study aimed to identify factors influencing epidural depth through a retrospective analysis of clinical data from PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.

Tipo de estudio

De observación

Inscripción (Estimado)

3278

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: Hongbo Zheng, MM
  • Número de teléfono: +8618040544926
  • Correo electrónico: zheng1283@163.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Hubei
      • Wuhan, Hubei, Porcelana, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contacto:
          • Hongbo Zheng, MM
          • Número de teléfono: +8618040544926
          • Correo electrónico: zheng1283@163.com
        • Contacto:

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 who underwent PCNL under continuous epidural anesthesia between January 2014 and December 2025. All patients were treated at a single academic medical center. Data were extracted from electronic medical records and anesthesia records.

Descripción

Inclusion Criteria:

  • Age ≥ 18 years
  • Successful epidural puncture and catheter placement using the midline approach
  • Clear documentation of puncture level and puncture depth in the anesthesia record

Exclusion Criteria:

  • Dural puncture during anesthesia (including those who subsequently had a successful repuncture)
  • Use of the paramedian approach for epidural puncture
  • Uncertain epidural anesthesia effect requiring combined general anesthesia
  • Incomplete clinical data

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
T11-T12
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the T11-T12 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
T12-L1
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the T12-L1 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
L1-L2
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the L1-L2 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
L2-L3
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry). Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated. After positioning in the lateral decubitus position, the L2-L3 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry. Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Epidural depth
Periodo de tiempo: Perioperative/Periprocedural
Epidural depth, defined as the vertical distance from the skin surface to the epidural space measured at the time of puncture using the loss-of-resistance technique via the midline approach. Depth was recorded from the needle shaft markings to the nearest 0.1 cm.
Perioperative/Periprocedural

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjusted R²
Periodo de tiempo: through study completion, an average of 1 month
The coefficient of determination adjusted for the number of predictors in the model, reflecting the proportion of variance in epidural depth explained by the predictive model at each puncture level. Higher values indicate better model fit.
through study completion, an average of 1 month
Root mean square error (RMSE)
Periodo de tiempo: through study completion, an average of 1 month
The square root of the average squared difference between the model-predicted epidural depth and the actual measured depth, expressed in cm. Lower values indicate better predictive accuracy of the model at each puncture level.
through study completion, an average of 1 month

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Hongbo Zheng, MM, Tongji Hospital

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)

30 de junio de 2026

Finalización primaria (Estimado)

31 de agosto de 2026

Finalización del estudio (Estimado)

31 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

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

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EDPN

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).

Marco de tiempo para compartir IPD

Immediately followingpublication. No end date.

Criterios de acceso compartido de IPD

Anyone who wishes to access the data.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

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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