Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539390
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-24
Brief Title:
Is Sedation Necessary for Transforaminal Epidural Injections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Is Sedation Necessary for Transforaminal Epidural Injections
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Detailed Description:
The study will be conducted by retrospectively scanning the files of patients with paracentralsubarticular protruded disc herniation and who underwent transforaminal epidural steroid injection TFESE to the lumbosacral region at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital between January 2022 and January 2024 In order to prevent heterogeneity magnetic resonance imaging MRI of the patients will be evaluated in consultation with a radiologist The common consensus classification created by the American Society of Spine Radiology ASSR American Society of Neuroradiology ASNR and North American Spine Society NASS is used to classify disc herniations will be used Numeric Rating Scale-11 NRS and Oswestry Disability Index ODI will be recorded from the patients files before the procedure in the first month and in the third month to evaluate age gender symptom duration pain and functionality The initial pain severity of the patients will be determined by the NRS-11 score and a decrease of 50 or more in the NRS-11 score in the first month after the procedure will be considered as benefiting from the treatment The Mg level of the patients before the procedure will be scanned in the hospital system and those that can be accessed will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None