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临床试验/NCT06098859
NCT06098859已完成不适用

Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Respiratory functions

研究概览

简要总结

Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy

详细描述

Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.

Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.

The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.

All patients underwent general anesthesia with the same method and medications.

Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has ASA II-IV score
  • Having open heart surgery

排除标准

  • Having a psychiatric illness
  • Using analgesic medication due to chronic pain
  • Uncooperative

结局指标

主要结局

Respiratory functions

时间窗: Postoperative 48 hours

Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement. Tachypnea:more than 20/min Fever: more than 37 C celcius Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)

Postoperative pain

时间窗: Postoperative 48 hours

Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale). Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)..... 10: Unbearable pain (the worst)

次要结局

  • Intensive care and hospital stay(postoperative 30 days)
  • Analgesic requirement. When the VRS was more than 4 points(Postoperative 48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Engin Ertürk

Prof. Dr

Karadeniz Technical University

研究点 (2)

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