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临床试验/NCT04906239
NCT04906239已完成不适用

The Effect of Bilateral Erector Spina Block on Postoperative Pain in Adult Cardiac Surgery: A Randomized, Clinical Study.

Kahramanmaras Sutcu Imam University4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月1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
40
试验地点
4
主要终点
Morphine consumption by PCA (Patient Control Analgesia)

研究概览

简要总结

Failure to adequately prevent pain after heart surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. Aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spinae Block, a new block.

详细描述

Failure to adequately prevent pain after heart 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 protection from pain in the lateral / posterior chest wall.

Ketamine and a2 agonists were used for intravenous analgesia to reduce opioid consumption. However, these drugs have potential side effects that limit their extensive clinical use as analgesic agents. The use of regional anesthetic techniques, e.g. thoracic epidural and thoracic paravertebral block, dural puncture, epidural hematoma, spinal cord injury, hypotension, pneumothorax, epidural abscess, ipsilateral Horner's syndrome Their use has declined due to the high failure rate of as much as 15% (especially for the thoracic epidural) and the significant possibility of complications.

Erector spinae (ESP) block, a new method, provides a wide multi dermatomal sensory block. In the T 4-5 spinous process, the bilateral ESP block provides analgesia from T2 to T9 sensory level and results in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block can provide sufficient analgesia for the median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Our aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spina Block, a new block.

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 (Care Provider)

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 will be included in the study.
  • Normal left ventricular function (alternating one, two and three vessels).
  • coronary artery patients scheduled for elective coronary artery surgery under cardiopulmonary bypass,
  • Valvular diseases planned for elective valve replacement with normal left ventricular function, ASD (Atrial Septal Defect) cases for atrial septal defect closure, and patients without left ventricular dysfunction (E / F≥ 50-55%) elective valve + CABG will be included in the study.

排除标准

  • Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
  • Patients who have had myocardial infarction within the past month
  • Recurrent cardiovascular surgery
  • Off-pump coronary artery bypass surgery (OPCAB)
  • Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
  • Patients with chronic renal failure, liver disease, active infection
  • Patients older than 80 years and smaller than 18 years
  • Patients with coagulation disorders

结局指标

主要结局

Morphine consumption by PCA (Patient Control Analgesia)

时间窗: The change from baseline in the postoperative period 1, 4, 12 and 24 hours after extübation

Morphine consumption used in case of pain

次要结局

  • Pain (VAS Score)(Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.)

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)

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