Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain

Официальное название

Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain: A Prospective Observational Study

Обзор

Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure commonly used for the management of lumbar radicular pain. It is intended to reduce inflammation around the affected nerve root, limit edema, and modulate nociceptive transmission, with the aim of relieving pain, improving physical function, and potentially reducing the need for surgery. Although TFESI may improve function and quality of life, treatment benefit is not uniform, and the degree of pain relief and patient satisfaction may differ across individuals. This prospective observational study aims to evaluate postprocedural pain intensity and patient satisfaction in individuals undergoing lumbar TFESI and to identify clinical and demographic factors associated with satisfaction. Demographic and clinical characteristics, medical and surgical history, procedural pain scores, anxiety level, postprocedural pain scores, sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be assessed 1 hour after the procedure using a Likert-based questionnaire, and operator satisfaction will also be documented. By examining patient-reported outcomes together with procedural and clinical variables, this study seeks to provide a more standardized assessment of real-world TFESI outcomes and to support better patient selection and follow-up strategies.

Подробное описание

Lumbar radicular pain is a common clinical problem that can substantially impair daily functioning and quality of life. Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure frequently used in the management of this condition.

In clinical practice, TFESI may provide pain relief, improve physical function, and in some patients reduce or delay the need for surgical intervention. However, its effectiveness is not uniform, and the magnitude and duration of benefit may vary across individuals. In some patients, symptom relief may be temporary, and recurrent pain may lead to repeat injection or surgical treatment. Published studies have also shown a wide range of treatment success rates, suggesting that patient-related and procedure-related factors may influence outcomes.

In this context, a more standardized evaluation of patient-reported outcomes after TFESI is needed. Pain intensity, anxiety level, and patient satisfaction are clinically relevant outcomes that may provide a more comprehensive understanding of the patient experience during and after the procedure. In particular, patient satisfaction may be influenced not only by postprocedural pain relief, but also by anxiety before or during the procedure, sedation status, procedural discomfort, and other clinical or demographic characteristics.

The aim of this prospective observational study is to quantitatively assess postprocedural pain, preprocedural anxiety, and patient satisfaction in patients undergoing lumbar TFESI, and to identify the clinical and demographic factors associated with patient satisfaction. The study is designed to reflect real-world clinical practice rather than protocol-driven intervention assignment.

A total of 120 participants who present to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital, who undergo lumbar TFESI, and who meet the inclusion and exclusion criteria will be enrolled after providing written informed consent. Demographic and baseline clinical data, including age, body mass index, primary diagnosis, comorbidities, pain intensity, and medical and surgical history, will be collected using a standardized data collection form.

Procedure-related assessments will also be documented in a standardized manner. Peak pain intensity during the procedure, measured using the Numeric Rating Scale (NRS), and pain intensity at 1 hour after the procedure will be recorded. Anxiety level will also be assessed and documented. Sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be evaluated at 1 hour after the procedure using a Likert-based satisfaction questionnaire.

By analyzing patient-reported and procedure-related outcomes together, this study aims to provide a clearer understanding of the factors associated with patient satisfaction after lumbar TFESI. The findings may help support more individualized patient selection, improve periprocedural assessment, and contribute to better follow-up strategies in routine clinical practice.

Вмешательства

• Процедура Fluoroscopy-guided lumbar transforaminal epidural steroid injection
  Routine fluoroscopy-guided lumbar transforaminal epidural steroid injection performed at the L2-3, L3-4, L4-5, or L5-S1 level(s) for the treatment of lumbar radicular pain.

Первичные конечные точки

• Patient satisfaction [Срок оценки: 1 hour after the procedure]

Вторичные конечные точки (2)

• Preprocedural anxiety level [Срок оценки: Before the procedure]
• Operator satisfaction [Срок оценки: Immediately after the procedure]

Критерии участия

Критерии включения

• Adults aged 18 to 80 years
• No prior history of any interventional pain procedure
• Ability to read and write in Turkish and to complete the study questionnaires
• Written informed consent provided.
• Planned lumbar transforaminal epidural steroid injection for radicular pain

Критерии исключения

• Refusal to provide written informed consent.
• Inability to complete the satisfaction questionnaires reliably due to lack of Turkish literacy, significant cognitive impairment or severe visual or hearing impairment
• Presence of major comorbidities such as decompensated cardiac or respiratory failure, uncontrolled arrhythmia or angina, myocardial infarction or stroke within the past 3 months, advanced liver or kidney failure, uncontrolled obstructive sleep apnea associated with morbid obesity, or severe pulmonary hypertension.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Mersin University Faculty of Medicine, Pain Clinic — Mersin

Публикации

• Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or s PMID 39164613
• Bahar-Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. The Effect of Pre-Treatment Depression, Anxiety and Somatization Levels on Transforaminal Epidural Steroid Injection: A Prospective Observational Study. Pain Physician. 2020 Jun;23(3):E273-E280. PMID 32517403
• Sencan S, Edipoglu IS, Bilim S, Gunduz OH. Does Coadministration of Transforaminal Epidural Steroid Injection with Sedation Improve Patient Satisfaction? A Prospective Randomized Clinical Study. Pain Physician. 2019 Jul;22(4):E287-E294. PMID 31337170

Идентификаторы

NCT: NCT07495501 · TFESI-PSAP-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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