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

NCT07495501 | Not Yet Recruiting

• 1 other identifier: TFESI-PSAP-2026
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disc Disease; Radiculopathy Lumbar; Radicular Pain

Keywords

Patient satisfaction; Sedation; Anxiety; Epidural steroid injection; Pain intensity

Outcome Measures

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.

  1 hour after the procedure

Secondary Outcomes (2)

• Preprocedural anxiety level

  Before the procedure

• Operator satisfaction

  Immediately after the procedure

Study Arms (1)

Patients Treated With Lumbar Transforaminal Epidural Steroid Injection

Adult patients with lumbar radicular pain undergoing routine fluoroscopy-guided lumbar transforaminal epidural steroid injection and followed with periprocedural and early postprocedural assessments of pain, anxiety, sedation status, and patient satisfaction.

Procedure: Fluoroscopy-guided lumbar transforaminal epidural steroid injection

Interventions

Fluoroscopy-guided lumbar transforaminal epidural steroid injection PROCEDURE

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.

Patients Treated With Lumbar Transforaminal Epidural Steroid Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Faculty of Medicine, Pain Clinic

Mersin, Turkey (Türkiye)

Location

Related Publications (3)

• 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 stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.

  PMID: 39164613 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Intervertebral disc disease; Patient Satisfaction; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mesut Bakır

  Mersin University Faculty of Medicine, Pain Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesut Bakır, Assoc.Prof

CONTACT

+905457450655; mesutbakir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Algology

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)