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临床试验/NCT06431880
NCT06431880已完成不适用

External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月30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
90
试验地点
2
主要终点
Total morphine consumption

研究概览

简要总结

The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

详细描述

Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

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)

入排标准

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

入选标准

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Scheduled for open thoracotomy

排除标准

  • Patients with neurological or intellectual disability.
  • Infection at the injection site.
  • Opioid addiction.
  • Allergic reaction to local anesthetics.
  • Coagulation abnormalities.
  • Drug abuse.
  • Pregnancy.
  • Severe liver and/or renal failure.
  • Uncontrolled hypertension.
  • Severe cardiovascular problems.
  • Diabetes mellitus.

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

次要结局

  • Mean arterial pressure(Till the end of surgery)
  • Degree of pain(24 hours postoperatively)
  • Heart rate(Till the end of surgery)
  • Time to the 1st rescue analgesia(24 hours postoperatively)
  • Intraoperative fentanyl consumption(Intraoperative)
  • Complications(24 hour postoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (2)

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