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

NCT ID: NCT06539390

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-08-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pain, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Is Sedation Necessary for Transforaminal Epidural Injections

Transforaminal Epidural Injections?

Intervention Type OTHER

Pain, lumbar disc herniation,Transforaminal Epidural Injections?

Interventions

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Transforaminal Epidural Injections?

Pain, lumbar disc herniation,Transforaminal Epidural Injections?

Intervention Type OTHER

Other Intervention Names

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Is Sedation Necessary for Transforaminal Epidural Injections?

Eligibility Criteria

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Inclusion Criteria

Patients aged 18-65, American Society of Anesthesiologists (ASA) 1-3, who underwent unilateral, single-level TFESE were included.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Halil Ibrahim Altun

pain specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Sedation in epidural injection

Identifier Type: -

Identifier Source: org_study_id

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