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临床试验/NCT06539390
NCT06539390已完成不适用

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

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
1
主要终点
Numeric Rating Scale-11 (NRS-11)

研究概览

简要总结

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.

详细描述

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 2021 and January 2024. In order to prevent heterogeneity, magnetic resonance imaging (MRI) of the patients will be evaluated in consultation with a radiologist. will be used. . 201 patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) 1-3, who underwent unilateral L-TFESI, were included in the study. The patient selection process is shown in Figure 1. The patients' magnetic resonance (MR) images were evaluated by a radiologist with 10 years of experience in the musculoskeletal system. The classification system used in the studies by Pfirmann et al. and Ghahreman et al. was used to grade nerve root compression based on MR imaging. According to this classification system, DH compression was graded as low-grade (1-2) or high-grade (3-4) nerve root compression The Numeric Rating Scale-11 (NRS-11) and Likert scale were recorded on the 4th day and 4th week before and after the procedure. It is stated that the outcome of epidural steroid injections can be predicted from the 4th day onwards

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Is Sedation Necessary for Transforaminal Epidural Injections

干预措施: Transforaminal Epidural Injections? (Other)

结局指标

主要结局

Numeric Rating Scale-11 (NRS-11)

时间窗: one month

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).

次要结局

  • Likert scale(four days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halil Ibrahim Altun

pain specialist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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