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Is Sedation Necessary for Transforaminal Epidural Injections?

Recruiting
Conditions
Pain, Chronic
Interventions
Other: Transforaminal Epidural Injections?
Registration Number
NCT06539390
Lead Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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.

Detailed Description

The study will be conducted by retrospectively scanning the files of patients with paracentral/subarticular 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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.

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Is Sedation Necessary for Transforaminal Epidural InjectionsTransforaminal Epidural Injections?-
Primary Outcome Measures
NameTimeMethod
Is Sedation Necessary for Transforaminal Epidural Injections?five months

numerical rating scala

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital

🇹🇷

Istanbul, Turkey

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