Clinical trial NCT06539390: Is Sedation Necessary for Transforaminal Epidural Injections?
Official title: Is Sedation Necessary for Transforaminal Epidural Injections?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Chronic
Keywords: Transforaminal Epidural Injections, Sedation,Pain
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Exclusion Criteria:

* Those with advanced heart failure and severe chronic lung and obstructive sleep apnea syndrome; Those with chronic diseases such as unregulated diabetes and hypertension; Those with a history of lumbar surgery; those with multi-level disc herniation; Those with malignancy or obesity; Those with psychiatric illness and progressive neurological disease; Patients without MRI were excluded from the study.

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.

Eligibility 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.

Primary outcomes:
measure: Is Sedation Necessary for Transforaminal Epidural Injections?
timeFrame: five months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: