Evaluating the need for sedation during epidural injections for back pain
Is Sedation Necessary for Transforaminal Epidural Injections?
This study is trying to see if patients with chronic low back pain from disc herniation need sedation during epidural injections and how it affects their pain and ability to function afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06539390 on ClinicalTrials.gov |
What this trial studies
This observational study examines the necessity of sedation for patients undergoing transforaminal epidural steroid injections (TFESE) for chronic low back pain due to disc herniation. It involves a retrospective analysis of patient files from the Algology Department at Kanuni Sultan Süleyman Training and Research Hospital, focusing on patients treated between January 2022 and January 2024. The study will assess pain severity and functionality using the Numeric Rating Scale and Oswestry Disability Index before and after the procedure, while also considering MRI evaluations for accurate classification of disc herniations. The goal is to determine if sedation impacts treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a body mass index under 35 and classified as ASA 1-3 who have undergone unilateral, single-level TFESE.
Not a fit: Patients with multiple-level disc herniations or those outside the specified age and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help streamline the procedure for epidural injections, potentially reducing the need for sedation and associated risks.
How similar studies have performed: While there are limited studies on this specific approach, the use of TFESE is well-established, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged 18-65, American Society of Anesthesiologists (ASA) 1-3, body mass index\<35 kg/m2, who underwent unilateral, single-level TFESE were included.
Where this trial is running
Istanbul
- Kanuni Sultan Süleyman Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: halil ibrahim altun
- Email: halilibrahim_altun@yahoo.com
- Phone: +905072774773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.