Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of hyperalgesia
研究概览
简要总结
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy.
详细描述
This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily cooperate with the study and sign an informed consent form;
- •Ages between 18 and 65;
- •American Society of Anesthesiologists (ASA) classification: I-III;
- •Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision.
排除标准
- •Refuse to participate in the trial;
- •Allergic to the anesthetics or analgesics;
- •Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system);
- •American Association of Anesthesiologists (ASA) classification: IV-V;
- •Unstable hemodynamics;
- •History of drug abuse or chronic pain;
- •Mental disorders or communication difficulties;
- •Died during or immediately after the operation.
结局指标
主要结局
Incidence of hyperalgesia
时间窗: Surgery to 48 hours after
a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound
The total amount of analgesics used in the perioperative period.
时间窗: Surgery to 48 hours after
During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics
次要结局
- Length of stay in hospital(the day before hospital discharge)
- Visual Analogue Scale(Extubation to 24 hours after)
- Postoperative complications(the day before hospital discharge)
- incidence of postoperative delirium(Day 7 after operation)