NCT05141136Unknown不适用
A Magnetic Resonance Imaging Study of the Spread of Local Anesthetic Solution in Patients Receiving Ultrasound-guided Paravertebral Block at the Thoracic 2 Spinal Level: Prospective Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Injectate spread on MRI imge
研究概览
简要总结
The purpose of this study is to analyze the spread of local anesthetic using magnetic resonance imaging after thoracic 2 paravertebral block in patients with cervical radiculopathy.
详细描述
- Ultrasound guided thoracic 2 paravertebral block will be done using sagittal scan or transverse scan.
- Clinical parameters will be monitored (temperature, perfusion index, assessment of sensory block and analgesic effect, vital sign, adverse events) after the nerve block.
- Cervical MRI will be taken 1 hour after the nerve block.
- Follow up 7 days and 28 days after the MRI at outpatient clinic (numeric rating scale, medication quantification scale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and those who analyze magnetic resonance imaging, are kept unaware of group assignments.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment
- •Diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy
- •Numeric rating score ≥ 4
- •19 years or older
排除标准
- •Cervical or upper thoracic spine surgical history
- •If the body mass index is 35 kg/m2 or more
- •If you have an allergy or hypersensitivity reaction to a local anesthetic
- •coagulation disorders
- •Local infection at the injection site
- •claustrophobia
- •If you have a metal insert such as a pacemaker
- •Patients who are unable to communicate and have cognitive impairment
- •If a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)
结局指标
主要结局
Injectate spread on MRI imge
时间窗: 1 hour after thoracic 2 paravertebral block
Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)
次要结局
- skin temperature(Before nerve block, after 30 minutes)
- pinprick and cold test(Before nerve block, after 30 minutes)
- Presence of adverse events(Before nerve block, after 30 minutes)
- numeric rating score(Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.)
- Blood pressure in mmHg(Before nerve block, after 30 minutes)
- perfusion index(Before nerve block, after 30 minutes)
- Pulse rate in /min(Before nerve block, after 30 minutes)
- medication quantification scale(Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day)
研究者
Do-Hyeong Kim
Professor
Gangnam Severance Hospital
研究点 (2)
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