Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections

February 7, 2023 updated by: Marmara University

Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Steroid Injections in Lumbar Radicular Pain

Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.

Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.

However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.

In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study group will consist of patients who are planned to receive transforaminal epidural steroid injection or erector spina plane block treatment by the clinician, and who want to participate in the study.

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Radicular low back pain
  • Failure to respond to conservative treatments
  • Single level lumbar nerve root compression due to disc herniation
  • Agree to participate in the research

Exclusion Criteria:

  • Patients younger than 18 years and older than 65 years
  • Those with non-radicular low back pain
  • Those with nerve root compression due to reasons other than disc herniation
  • Those with Modic type-1 changes in lumbar MRI
  • Those with spinal stenosis or spondylolisthesis
  • Those diagnosed with spondylodiscitis
  • Pregnant
  • Those with inflammatory rheumatic disease
  • Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Those who had lumbar radicular pain
Patients with lumbar radicular pain identified by inclusion and exclusion criteria
Procedure: Transforaminal Epidural Steroid Injection
In the TFESI group, all patients were positioned prone. The injection site was cleaned with povidone-iodine 3 times and a sterile drape was applied. Short-acting local anesthesia (3 mL of 2% prilocaine) was applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle was inserted just below the pedicle. It was advanced into the subpedicular space using the coaxial technique under the intermittent guidance of fluoroscopy. The needle position was confirmed through a lateral view. Using lateral views, the needle was placed at the posterior one-third of the foramen. Using the anteroposterior view, one to 2 mL of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 8 mg (two mL) of dexamethasone, 2 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride was injected.
Procedure: Erector Spina Plane Block
Patients are placed in the prone position to determine the vertebrae in the middle of the involved area. Following the provision of aseptic conditions, the spinous process of the vertebral midline is visualized using a high-frequency (8 MHz) linear ultrasound (USG) probe. The transverse process is, then, visualized approximately at the 3 cm lateral from the midline and the erector spinae muscle is visualized on it. The 22-gauge 50 mm block needle is advanced towards the in-plane section craniocaudally and the transverse process is touched. Then the needle is then withdrawn minimally to confirm that it is between the erector spinae muscle and the transverse process through hydrodissection. Following that, 5 mL from 0.5% bupivacaine hydrochloride, 8 mg dexamethasone and 3 ml saline is administered and local anesthetic spread is confirmed by USG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NRS (Numeric Rating Scale)
Time Frame: at first hour, at three weeks, at 3 months, at 6 months
≥50% reduction in the NRS scores at month 6 relative to the initial NRS scores.
at first hour, at three weeks, at 3 months, at 6 months
Change in ODI (Oswestry Disability Index)
Time Frame: at first hour, at three weeks, at 3 months, at 6 months

≥40% reduction in ODI scores at month 6 relative to the initial ODI scores.

(ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
at first hour, at three weeks, at 3 months, at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-SK-YO-17.01.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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