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Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery (DISCOPAIN)

9 de septiembre de 2026 actualizado por: Saint-Gregoire Private Hospital Center

The lifetime prevalence of lumbosacral radiculopathy is 3 to 5 percent. The most common cause is a lumbar disc herniation. In 10 to 20 percent of patients, medical treatment is insufficient, and surgery is recommended. Lumbar discectomy is the standard surgical treatment. In recent years, minimally invasive techniques-and endoscopic approaches in particular-have become widely adopted.

The main advantage of these techniques lies in their reduced invasiveness, which allows for the preservation of muscle and ligament structures, with less extensive detachment and cutting. This preservation is likely to enable faster rehabilitation during the first few weeks and months after surgery, as well as a shorter hospital stay.

However, the available data focus primarily on medium- and long-term outcomes, and few studies have specifically examined early postoperative pain. Yet this immediate period is a critical factor, particularly regarding patient comfort, analgesic use, and length of hospital stay; it is a major determinant of the quality of immediate recovery. There is very little robust comparative data from real-world clinical settings evaluating the impact of surgical technique on early postoperative pain following lumbar discectomy.

In this context, this study aims to compare changes in short-term low back pain intensity following lumbar discectomy, depending on the technique used (endoscopic versus conventional open surgery), under real-world clinical conditions.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

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

Ubicaciones de estudio

  • Francia
      • Saint-Grégoire, Francia, 35760
        • Reclutamiento
        • Centre hospitalier Privé Saint-Grégoire
        • 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

Descripción

Inclusion Criteria:

  • Have had radicular and/or lower back pain for more than 6 weeks despite proper medical treatment, leading to the decision to schedule surgery
  • Have symptoms consistent with an MRI showing a herniated disc

Exclusion Criteria:

  • History of lumbar surgery
  • Complex Regional Pain Syndrome (CRPS) type 1 or 2
  • Multiple affected levels
  • Cauda equina syndrome
  • Unscheduled surgery
  • Spondylolisthesis
  • Significantly narrowed lumbar canal (Schizas C or D)
  • Pregnant, laboring, or breastfeeding women
  • Severe psychiatric disorder
  • Unwilling subject who cannot give consent or cannot return for scheduled visits as per the protocol
  • Person under legal protection (guardianship, conservatorship, or judicial safeguard)
  • Person deprived of liberty by judicial or administrative order
  • Person not covered by social security

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Endoscopis surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical site using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). The approach is percutaneous and transmuscular, using one channel for instruments and another for the endoscopic camera. After exposing the spinal canal, the nerve root is identified and protected. The herniated disc is then accessed following an incision in the posterior longitudinal ligament and resected using a disc forceps. The procedure concludes with skin closure.
Procedimiento: Endoscopic surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical site using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). The approach is percutaneous and transmuscular, using one channel for instruments and another for the endoscopic camera. After exposing the spinal canal, the nerve root is identified and protected. The herniated disc is then accessed following an incision in the posterior longitudinal ligament and resected using a disc forceps. The procedure concludes with skin closure.
Otro: Open surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical level using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). A skin incision is made to allow for a posterior approach with muscle dissection. Recalibration is performed to expose the nerve structures. The nerve root is identified and protected; the herniated disc is then accessed after incision of the posterior longitudinal ligament and resected using a disc forceps. Closure is performed layer by layer (fascia, subcutaneous tissue, skin).
Procedimiento: Open surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical level using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). A skin incision is made to allow for a posterior approach with muscle dissection. Recalibration is performed to expose the nerve structures. The nerve root is identified and protected; the herniated disc is then accessed after incision of the posterior longitudinal ligament and resected using a disc forceps. Closure is performed layer by layer (fascia, subcutaneous tissue, skin).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To compare, under real-world clinical conditions, changes in the intensity of short-term low back pain following lumbar discectomy, based on the surgical technique used: endoscopic versus open surgery
Periodo de tiempo: day 3
Change in lumbar Visual Analog Scale (VAS) between preoperative and Day 3. VAS provides a pain intensity score out of 10, 0 representing "no pain" and 10 representing "pain as bad as it could possibly be".
day 3

Colaboradores e Investigadores

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

Patrocinador

Saint-Gregoire Private Hospital Center

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 (Actual)

4 de septiembre de 2026

Finalización primaria (Estimado)

4 de septiembre de 2028

Finalización del estudio (Estimado)

1 de agosto de 2029

Fechas de registro del estudio

Enviado por primera vez

10 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de agosto de 2026

Publicado por primera vez (Actual)

14 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

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

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-41-STG

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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