Lumbar Disc Hernia, Erector Spinae Plane Block, Ilesi

NCT07184554 | Recruiting

• 1 other identifier: Ilesi block vs esp
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as an observational study. Patients who have been treated and completed treatment for lumbar discopathy in our clinic will be followed. Patients will not be divided into groups beforehand, and this will not cause changes to the treatment plan. Patients who have undergone fluoroscopy-guided lumbar interlaminar epidural steroid injection (LESI) and ultrasound-guided lumbar erector spinae plane block (LESP), routinely performed in our clinic for the treatment of back and leg pain due to lumbar disc herniation, will be compared to the effectiveness of these methods on pain at baseline before the procedure and at 2, 6, and 12 weeks afterward using the Visual Analogue Scale for Pain Relief (VAS) and Oswestry Disability Index (ODI). The baseline values will be recorded from the patient files and by request before the start of follow-up.

Conditions

Lumbar Disc Herniation

Keywords

espb, lesi, lumbar disc herniation

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

  Change from baseline to 2nd, 6th and 12th weeks after treatment

Secondary Outcomes (1)

• oswestry disability index

  Change from baseline to 2nd, 6th and 12th weeks after treatment

Study Arms (2)

us-guided espb

ACTIVE COMPARATOR

us-guided espb for ldh

Procedure: us-guided espb

fl-guided Ilesi

ACTIVE COMPARATOR

fl-guided Ilesi for ldh

Procedure: fl-guided Ilesi

Interventions

us-guided espb PROCEDURE

Hemodynamic monitoring is provided. The lumbar region where the procedure will be performed is cleaned with povidone iodine. Sterile draping is provided. For the lumbar erector spinae plane block application, a 5 Hz convex ultrasound probe is first placed sagittally over the desired level of the lumbar vertebra. After the spinous processes are visualized, the ultrasound probe is laterally shifted in the sagittal plane, first visualizing the laminae, then the facet joints, and finally the transverse processes. The erector spinae muscles are visualized over the transverse processes. The skin and subcutaneous tissue are then anesthetized with 2 cc of 2% lidocaine. A spinal needle is inserted from the anesthetized area in the same plane as the ultrasound probe (in plane) and contacts the relevant transverse process. Thanks to the real-time imaging advantage of ultrasound, a certain distance is maintained from the nerves and vascular structures. Once the appropriate location is reached, a m

us-guided espb

fl-guided Ilesi PROCEDURE

For lumbar interlaminar epidural steroid injection, the anterior view of the desired level is obtained under fluoroscopy to visualize the relevant interlaminar epidural space. The skin and subcutaneous tissue are anesthetized with a local anesthetic. A paramedian approach is used to enter the target interlaminar space with an epidural needle using a negative pressure injector. The lateral view is checked using fluoroscopy. 2 cc of opaque material is administered, and its presence in the epidural space is confirmed from the lateral and anterior-posterior views. A mixture of steroid and local anesthetic (8 mg dexamethasone, 3 cc 5mg/ml bupivacaine, and SF for a total of 10 cc) is injected. The needle is removed in a controlled manner and the needle site is closed. After the procedure, patients are monitored in the recovery unit for 60 minutes and then transferred to the ward for follow-up. Patients who have completed their 1-hour follow-up in the ward are discharged.

fl-guided Ilesi

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic low back pain caused by L4-L5 and L5-S1 lumbar disc herniation accompanied by radicular pain, including those diagnosed by MRI, will be included.
• Patients with low back pain above VAS 5 for more than 6 weeks will be included.
• Failure of pain treatment with conservative methods such as analgesics and physical therapy

You may not qualify if:

• Patients who have previously undergone lumbar surgery,
• Patients with spinal deformity and stenosis,
• Patients with uncontrolled diabetes
• Patients allergic to the drugs to be used will not be included in the study.
• Presence of psychiatric comorbidity
• Local or systemic infection
• Coagulopathy
• Presence of rheumatological disease

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Central Study Contacts

EMINE YUKSEL

CONTACT

+905453489378; eminecan_02@hotmail.com

GOKHAN YILDIZ

CONTACT

+905059272589; gkoyldz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: September 20, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

TU (1)