Impact of Sedation on Patient Satisfaction, Radiation Exposure, and Complications in Lumbar Transforaminal Epidural Steroid Injections: A Retrospective Cohort Study

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: Pain, Chronic
• Intervention / Treatment: Other: Transforaminal Epidural Injections?

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

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34000
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Is Sedation Necessary for Transforaminal Epidural Injections	Other: Transforaminal Epidural Injections?; Pain, lumbar disc herniation,Transforaminal Epidural Injections?; Other Names: Is Sedation Necessary for Transforaminal Epidural Injections?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale-11 (NRS-11)	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	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

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

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

• Keywords: Transforaminal Epidural Injections, Sedation,Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• 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