Erector Spinae Plane Block in Robotic Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Analogic Scale 12h
研究概览
简要总结
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic.
At 3 months the patients will be contacted to assess for pain and ask them for they life quality.
详细描述
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire.
The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description.
Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed.
Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours.
The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Robotic Cardiac Surgery
- •Accepts to participate
排除标准
- •Use of other regional anesthesia technics
- •Presence of chronic Pain
- •Psychiatric pathology, drug abuse
- •Allergy or intolerance to local anesthetics
研究组 & 干预措施
Morphine infusion
IV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours.
干预措施: Morphine injection (Drug)
ESP Block analgesia
After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed.
An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered.
干预措施: ESP Block (Procedure)
ESP Block analgesia
After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed.
An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered.
干预措施: Morphine injection (Drug)
结局指标
主要结局
Visual Analogic Scale 12h
时间窗: 12 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Accumulated opioid dose 12h
时间窗: 12 postoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 24h
时间窗: 24 ostoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 48h
时间窗: 48 postoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Visual Analogic Scale 24h
时间窗: 24 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 48h
时间窗: 48 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
次要结局
- EQ 5-Dimensions 5-Levels(Preoperative and 3 months after surgery)
- Brief Pain Scale(3 months after surgery)
- Neuropathic pain assessment(3 postoperative months)