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Completed

NCT Number: NCT06539390

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Transforaminal Epidural Injections?

Other

Pain, lumbar disc herniation,Transforaminal Epidural Injections?

Other names: Is Sedation Necessary for Transforaminal Epidural Injections?

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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