Magnetic Resonance Imaging Analysis of the Spread of Local Anesthetic Solution After Ultrasound-guided Erector Spinae Plane Blockade
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Magnetic resonnance Imaging spread
研究概览
简要总结
Background and Objectives: The Thoracic Erector Spinae Plane Blockade (ESPB) is a regional anesthesia technique recently described by Forero M in November 2016 , whereby local anesthetic (LA) is injected in the inter Fascial space between posteriorly the fascia of Erector Spinae Muscles (IFS-ESP) (the iliocostalis, longissimus, and spinalis muscles ) and anteriorly the inter-transverse ligament to achieve multi-metameric analgesia for thoracic or upper abdominal surgery.
Recent studies published showed controversies on the spread of the local anesthetic and also the clinical efficiency .
The clarification of mechanism of the paravertebral block is one example for the effectiveness of Magnetic Resonance imaging (MRI) in this context We therefore designed a prospective study in volunteers to examine the spread of LA via MRI investigation in correlation with the extent of somatic block after a standardized ultrasound (US) guided ESPB. Our study will study the spread at T4 or T5 level which is the level used for most of thoracic, cardiac and breast surgeries to determine if dye would spread anteriorly to the involve or igins of the ventral and dorsal branches of the spinal nerves.
Methods:
After ethical committee approval we will select 10 Healthy volunteers to perform Unilateral ESP single shot block with a very low dose of Local anesthetic (LA) (Ropivacaine 0.5% 1 mg/kg (Maximal dose recommended = 3 mg/kg ) mixed with 0,1ml gadolinium After injection an ultrasound image of the spread of the LA with an easy 3 Dimension will be acquired. 10 and 30 minutes after injection a MRI will be performed to analyze the ultrasound spread. An Evaluation of the extension of Sensory Blockade.
Patient will be kept under monitoring for 1,5 hours to assess any complication Sensory block will be assessed. At 1 week after the study day, all volunteers will undergo an investigation of the puncture sites to exclude puncture- related infection or hematoma.
Statistical analysis will be done The cranio-caudal spread of LA will be recorded (US + MRI) and described for each of the volunteers.
详细描述
Screening Visit Ten healthy volunteers aged between 18 and 45 year olds Will be enrolled in the study. Prior to inclusion in the study, we informed them about the nature, scope, and the procedures of the study and about the particular study-related risks.
Exclusion criteria were defined as follows:
-
Anatomical abnormalities of the thoracic spine identified by physical examination.
-
Body mass index ≥30 kg/m2
-
Medical contra-indication for Conscious MRI
-
Claustrophobia
-
Metal implants (pacemaker and others)
-
Known allergy or hypersensitivity against Ropivacaine or other amino-amide LAs
-
Participation in another clinical study within the last 4 weeks prior to study
-
Coagulopathies in the medical history
-
Abnormalities in electrocardiography that are considered clinically relevant such as atrio-ventricular block or bradycardia After signing the informed consent, each volunteer will go under a general physical examination, including patient history and drawing of blood for the laboratory (red and white blood count, and standard blood coagulation parameters).
In addition, an electrocardiogram as well as determination of blood pressure and heart rate will be performed. when all inclusion criteria will be met, a bilateral cross-sectional ultrasound examination of the IFS-ESP at the thoracic 4 (T4) level will be performed to confirm a clear identification of the ultrasound landmarks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between 18 and 45 year old
排除标准
- •Refusal of the volunteer
- •Anatomical abnormalities of the thoracic spine identified by physical examination.
- •Body mass index ≥30 kg/m2
- •Medical contra-indication for Conscious MRI
- •Claustrophobia
- •Metal implants (pacemaker and others)
- •Known allergy or hypersensitivity against Ropivacaine or other amino-amide LAs
- •Participation in another clinical study within the last 4 weeks prior to study
- •Coagulopathies in the medical history
- •Abnormalities in electrocardiography that are considered clinically relevant such as atrio-ventricular block or bradycardia
结局指标
主要结局
Magnetic resonnance Imaging spread
时间窗: 40 minutes after injection
spread of the local anesthetic
Sensory blockade evaluation
时间窗: 4 hours after local anesthetic injection
Pinprick testing from cervical dermatomes to T12 dermatome
次要结局
未报告次要终点