Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery: A Study to Interleukin-6 and Cortisol Plasma Concentration, Total Opioid Dose, and Time to First Opioid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Interleukin-6 plasma concentration
研究概览
简要总结
This Study aimed to assess The Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery
详细描述
This is a double blind randomized controlled trial. Thirty-two subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the treatment group who will get Bilateral Transversus Thoracis Muscle Plane Block after induction of anesthesia and the second group will be the control group who will not get any regional block during surgery. After surgery, time to first morphine dose, total morphine consumption in 24 hours, extubation time, and adverse events will be recorded for both group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-75 years old
- •Patients who will undergo elective open heart surgery with median sternotomy approach
排除标准
- •Patient who does not agree to be included in this study
- •weight <45kg or >75 kg
- •Patient with chronic obstructive pulmonary disease
- •Patient with chronic kidney disease who needs regular hemodialysis.
- •Patient with local infection in the injection area for transversus thoracis muscle plane block
- •Patient with chronic pain
- •Patient with history of chronic analgetics drugs usage
- •Patient who is contraindicated for local anesthetics
- •Patient with communication disability
- •Patient with cognitive disorders
- •Patient with severe psychiatrics disorders, such as schizophrenia and bipolar disorder
研究组 & 干预措施
Bilateral transversus thoracis muscle plane block
Regional block will be performed after induction of anesthesia by anesthesiologist on duty who is not part of investigators for this study. The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided
干预措施: Bilateral transversus thoracis muscle plane block (Procedure)
Control
Needle will be put in the superficial skin on the same area as transversus thoracis muscle plane block area without any drugs injected into the injection area
干预措施: Control (Procedure)
结局指标
主要结局
Interleukin-6 plasma concentration
时间窗: 48 hours
Interleukin-6 plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery
Cortisol plasma concentration
时间窗: 48 hours
cortisol plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery
次要结局
- total morphine dose(24 hours)
- time to first morphine(24 hours)
研究者
Aida Rosita Tantri
Principal Investigator
Indonesia University