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

NCT06539390 | Completed

• 1 other identifier: Sedation in epidural injection
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic

Keywords

Transforaminal Epidural Injections, Sedation,Pain

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale-11 (NRS-11)

  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).

  one month

Secondary Outcomes (1)

• Likert scale

  four days

Study Arms (1)

Is Sedation Necessary for Transforaminal Epidural Injections

Other: Transforaminal Epidural Injections?

Interventions

Transforaminal Epidural Injections? OTHER

Pain, lumbar disc herniation,Transforaminal Epidural Injections?

Also known as: Is Sedation Necessary for Transforaminal Epidural Injections?

Is Sedation Necessary for Transforaminal Epidural Injections

Eligibility Criteria

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

Study Population

Exclusion Criteria: * Patients with ASA 4 and above, * patients with a history of lumbar surgery, * patients with multi-level disc herniation, * malignancy, * psychosis, * patients without MRI imaging, * patients with known allergies to the drugs used, * patients with bleeding disorders, * patients with infection at the injection site, and pregnant patients were excluded from the study.

You may qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pain specialist

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: August 6, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

TU (1)