Impact of Sedation on Patient Satisfaction, Radiation Exposure, and Complications in Lumbar Transforaminal Epidural Steroid Injections: A Retrospective Cohort Study
January 18, 2026 updated by: Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
Radicular low back pain due to disc herniation is frequently observed.
There are rest, medical treatments, physical medicine modalities, interventional procedures for pain and surgical options in the treatment of lumbar disc herniations.
Epidural interventional methods can be applied safely and effectively in patients who do not respond to conservative treatment.
Transforaminal epidural steroid injections (TFESE) are frequently used in the interventional treatment of lumbosacral radicular low back pain.
TFESE is applied targetedly under fluoroscopy guidance in disc herniation.
Therefore, the chance of success increasesTFESE, which is considered a minimally invasive procedure today, is frequently preferred in interventional pain treatments.
TFESE can be performed with or without sedation, depending on the preference of the physician and the patient, the patient's comorbidities, the infrastructure of the hospital and the health presentation.
There are conflicting and limited studies on whether sedation is necessary in interventional pain procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted by retrospectively scanning the files of patients with paracentral/subarticular protruded disc herniation and who underwent transforaminal epidural steroid injection (TFESE) to the lumbosacral region, at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital, between January 2021 and January 2024.
In order to prevent heterogeneity, magnetic resonance imaging (MRI) of the patients will be evaluated in consultation with a radiologist.
will be used. .
201 patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) 1-3, who underwent unilateral L-TFESI, were included in the study.
The patient selection process is shown in Figure 1.
The patients' magnetic resonance (MR) images were evaluated by a radiologist with 10 years of experience in the musculoskeletal system.
The classification system used in the studies by Pfirmann et al. and Ghahreman et al. was used to grade nerve root compression based on MR imaging.
According to this classification system, DH compression was graded as low-grade (1-2) or high-grade (3-4) nerve root compression The Numeric Rating Scale-11 (NRS-11) and Likert scale were recorded on the 4th day and 4th week before and after the procedure.
It is stated that the outcome of epidural steroid injections can be predicted from the 4th day onwards
Study Type
Observational
Enrollment (Actual)
201
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
-
-
-
Istanbul, Turkey (Türkiye), 34000
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Exclusion Criteria:
- Patients with ASA 4 and above,
- patients with a history of lumbar surgery,
- patients with multi-level disc herniation,
- malignancy,
- psychosis,
- patients without MRI imaging,
- patients with known allergies to the drugs used,
- patients with bleeding disorders,
- patients with infection at the injection site, and pregnant patients were excluded from the study.
Description
Inclusion Criteria:
Patients aged 18-65, American Society of Anesthesiologists (ASA) 1-3, who underwent unilateral, single-level TFESE were included.
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 |
|---|---|
|
Is Sedation Necessary for Transforaminal Epidural Injections
|
Pain, lumbar disc herniation,Transforaminal Epidural Injections?
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale-11 (NRS-11)
Time Frame: one month
|
It is an 11-point numerical scale where patients can rate their pain on a scale of 0 (no pain) to 10 (the most severe pain they have ever felt).
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likert scale
Time Frame: four days
|
It is a satisfaction rating scale where satisfaction is rated on a scale of 1 to 5, with 1 being not satisfied at all and 5 being very satisfied, and the higher the score, the higher the satisfaction.
|
four days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2024
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 30, 2025
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
August 1, 2024
First Posted (Actual)
August 6, 2024
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 18, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sedation in epidural injection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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