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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMersin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will include adult patients presenting to the pain medicine outpatient clinic of Mersin University Faculty of Medicine Hospital who provide written informed consent, meet the eligibility criteria, and undergo lumbar transforaminal epidural steroid injection during the study period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fluoroscopy-guided lumbar transforaminal epidural steroid injection

    Procedure/Surgery

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Patients Treated With Lumbar Transforaminal Epidural Steroid Injection1 intervention

Trial outcomes

Primary outcomes

1

Patient satisfaction

Patient satisfaction will be assessed at 1 hour after lumbar transforaminal epidural steroid injection using a Likert-based satisfaction questionnaire.

Time frame
1 hour after the procedure

Secondary outcomes

1

Preprocedural anxiety level

Preprocedural anxiety level will be assessed using the Spielberger State-Trait Anxiety Inventory (STAI).

Time frame
Before the procedure
2

Operator satisfaction

Operator satisfaction with the procedure will be assessed using the study-specific satisfaction assessment.

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

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