Lumbar Disc Hernia, Erector Spinae Plane Block, Ilesi

ConditionLumbar Disc Herniation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorDiskapi Teaching and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

us-guided espb
Procedure/Surgery
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
fl-guided Ilesi
Procedure/Surgery
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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: us-guided espbActive comparator 1 intervention

Group B: fl-guided IlesiActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

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

Secondary outcomes

oswestry disability index

The Oswestry Disability Index is an index derived from the Oswestry Back Pain Questionnaire, which is used by clinicians and researchers to measure disability in terms of back pain and quality of life.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diskapi Teaching and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now