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

NCT07766031 | Not Yet Recruiting

• 1 other identifier: 2025-41-STG
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Herniated Lumbar Disc; Radicular and/or Lower Back Pain

Keywords

postoperative pain; discectomy; herniated disc; endoscopy

Outcome Measures

Primary Outcomes (1)

• 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

  Change in lumbar VAS between preoperative and Day 3

  day 3

Study Arms (2)

Endoscopis surgery

EXPERIMENTAL

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

Open surgery

OTHER

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

Interventions

Endoscopic surgery PROCEDURE

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.

Endoscopis surgery

Open surgery PROCEDURE

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).

Open surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Gregoire Private Hospital Center: lead

MeSH Terms

Conditions

Pain, Postoperative; Intervertebral Disc Displacement

Interventions

Endoscopy; Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Jonathan LEBHAR, Dr

CONTACT

+332 23 25 30 70; jlebhar@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 4, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08