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

9 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Saint-Grégoire, Frankrijk, 35760
        • Werving
        • Centre hospitalier Privé Saint-Grégoire
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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.
Ander: 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).
Procedure: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Saint-Gregoire Private Hospital Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 september 2026

Primaire voltooiing (Geschat)

4 september 2028

Studie voltooiing (Geschat)

1 augustus 2029

Studieregistratiedata

Eerst ingediend

10 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2026

Eerst geplaatst (Werkelijk)

14 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-41-STG

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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