Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

9. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Saint-Grégoire, Frankrig, 35760
        • Rekruttering
        • Centre hospitalier Privé Saint-Grégoire
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Andet: 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).
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. september 2026

Primær færdiggørelse (Anslået)

4. september 2028

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

10. august 2026

Først indsendt, der opfyldte QC-kriterier

10. august 2026

Først opslået (Faktiske)

14. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner