A Volunteer Study to Determine the Anatomical Distribution of Injectate, the Extent of Sensory Block, and the Pharmacokinetics of Ropivacaine Following Erector Spinae Plane (ESP) Blocks.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area of Dermatomal Sensory Loss at 20 Min
研究概览
简要总结
The primary objectives of this study are to define the extent of dermatomal anesthesia and anatomical spread of injectate (as defined by MRI imaging) that is provided by an ESP block at the T5 level, using twenty milliliters of 0.5% ropivacaine.
The secondary objectives include: 1) the measurement of changes in hemodynamic parameters associated with the ESP block, 2) the duration of sensory effects provided by ropivacaine with or without epinephrine, 3) the venous plasma concentration of ropivacaine associated at various time intervals after completion of the ESP block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 60 inclusive
- •Weight between 60 and 100 kg inclusive
- •Height 160 to190 cm inclusive
排除标准
- •Pregnant females
- •Chronic medical condition requiring medication
- •History of previous major spinal, abdominal or thoracic surgery
- •Congenital abnormalities of the spine, back, thorax or abdomen
- •History of major trauma to the thorax or abdomen;
- •Allergy to ropivacaine or other amide local anesthetics
- •The presence of any metallic implant in their body
- •Any contraindication to magnetic resonance imaging as determined by completion of a standard questionnaire administered to all patients undergoing magnetic resonance imaging.
- •Allergy to Gadolinium radiological contrast agent.
研究组 & 干预措施
Ropivacaine with Epinephrine
Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
干预措施: Ropivacaine (Drug)
Ropivacaine with Epinephrine
Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
干预措施: Epinephrine (Drug)
Ropivacaine without Epinephrine
Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Area of Dermatomal Sensory Loss at 20 Min
时间窗: 20 minutes from the time of the ESP block
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 60 Min
时间窗: 60 minutes from the time of the ESP block
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 120 Min
时间窗: 120 minutes from the time of the ESP block
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss at 240 Min
时间窗: 240 minutes from the time of the ESP block
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 360 Min
时间窗: 360 minutes from the time of the ESP block
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Venous Plasma Concentration of Ropivacaine at 20 Min
时间窗: These samples will be repeated at 20 minutes after completion of the injection of active drug.
3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 60 Min
时间窗: These samples will be repeated at 60 minutes after completion of the injection of active drug.
3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 90 Min
时间窗: These samples will be repeated at 90 minutes after completion of the injection of active drug.
3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 120 Min
时间窗: These samples will be repeated at 120 after completion of the injection of active drug.
3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 240 Min
时间窗: These samples will be repeated at 240 minutes after completion of the injection of active drug.
3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Volume of Injectate Spread Measured Using MRI at 30 Min
时间窗: 30 minutes from the time of the ESP block
The subject will undergo two MRIs to determine the spread of the anesthetic.
Volume of Injectate Spread Measured Using MRI at 90 Min
时间窗: 90 minutes from the time of the ESP block
The subject will undergo two MRIs to determine the spread of the anesthetic.
次要结局
未报告次要终点
研究者
Sanjib D Adhikary
Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho
Milton S. Hershey Medical Center