跳至主要内容
临床试验/NCT04090099
NCT04090099已完成不适用

Ultrasound-GTrialuided Bilateral Erector Spina Block Versus Parasternal Block in Adult Cardiac Surgery: A Prospective, Randomized, Controlled Study.

Kahramanmaras Sutcu Imam University4 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
4
主要终点
Morphine consumption by PCA

研究概览

简要总结

Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.

详细描述

99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PS (Parasternal Intercostal Block n = 31) will be randomized. Randomization was achieved by randomly assigning patients to computer-generated random numbers. It will be explained that patients can receive both intravenous analgesia treatment and both blocks that are thought to be done. Patients will be told to express the degree of postoperative pain in the preoperative preparation room using a numerical scoring scale (NRS) between 0 and 10 (no pain at 0, no pain at 10). The vascular access will be opened in the pre-operative preparation room and 2 mg demizolam will be made. All preoperative cardiac drugs, except antiplatelet and anticoagulants, will be continued until the morning of surgery.

Demographic structures, cardiopulmonary bypass time, aortic cross clamp time, surgical time, ejection / fraction values will be recorded.

Weight and height of patients will be recorded (BMI). Preoperative, blood group and typing, full hemogram, liver function tests, renal function tests, chest radiography, electrocardiography, 2D transthoracic echocardiography and coronary angiography will be done as routine investigations.

Platelet count, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time will be checked in all patients.

Constructional blocks:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

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

入选标准

  • Male and / or female patients
  • Aged 18-65 years
  • Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
  • Valve diseases with normal left ventricular function,
  • ASD (Atrial Septal Defect) cases for atrial septal defect closure
  • Patients with valve + CABG without left ventricular dysfunction will be included in the study.
  • Ejection- Fraction> 50-55

排除标准

  • Emergency and repeat heart surgery cases
  • Advanced left coronary artery disease and left ventricular dysfunction
  • Receiving preoperative inotropic support therapy,
  • With mitral stenosis with atrial tombus,
  • With low cardiac out put syndrome,
  • Need intra-aortic balloon pump during surgery,
  • Bleeding and coagulation disorder,
  • Liver and kidney dysfunction,
  • Patients with uncontrolled diabetes mellitus and coronary artery pulmonary disease,
  • Opioid, analgesic and bupivacaine allergy,
  • Patients with atrial fbrilation using anticoagulants
  • Patients with cognitive dysfunction
  • Patients who do not want to participate in the study

结局指标

主要结局

Morphine consumption by PCA

时间窗: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation

Morphine consumption used in case of pain

次要结局

  • Change Blood Gas(Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,)
  • Change Pain Scores(Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation)
  • Blood Pressure(Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yavuz Orak

Assistant Professor

Kahramanmaras Sutcu Imam University

研究点 (4)

Loading locations...

相似试验