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临床试验/NCT04575272
NCT04575272已完成不适用

Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年8月3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
62
试验地点
2
主要终点
Change in pain score

研究概览

简要总结

The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.

详细描述

Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.

Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.

the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).

The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.

There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

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
Double (Participant, Outcomes Assessor)

盲法说明

neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.

排除标准

  • significant head injury and unconsciousness (GCS less than 14)
  • Patients with significant pain from other injuries
  • pathological obesity (body mass index ≥35)
  • history of drug allergy local anesthetics
  • local infection at the injection site
  • inability to obtain consent from patient or surrogate, and patient refusal

结局指标

主要结局

Change in pain score

时间窗: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"

patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"

次要结局

  • heart rate(before and after the block every "2hours" for 3 days)
  • peripheral arterial oxygen saturation (SpO2)(before and after the block every "2hours" for 3 days)
  • Change in inspiratory volumes (mL)(before and after block at "90 minutes" then every "12hours" for 3 days)
  • change in Serum beta-endorphin level(before procedure and at 24 hours post procedure)
  • mean arterial blood pressure(before and after the block every "2hours" for 3 days)
  • Lung Ultrasound Score (LUSS)(before and after block at "90 minutes" then every "24 hours" for 3 days)

研究者

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

Mohammed mamdouh mohammed mahmoud

Principal Investigator

Assiut University

研究点 (2)

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