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临床试验/NCT07823920
NCT07823920尚未招募不适用

The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2027年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.

研究概览

简要总结

In the emergency department, tube thoracostomy is a common critical procedure to manage symptomatic pleural issues such as pneumothorax and pleural effusion.[1] This technique employed to remove air or fluid from the pleural cavity, restore negative intrapleural pressure and let the lungs expand again to help normal cardiopulmonary function to be restored again. [2] However, the procedure is often associated with significant pain, with approximately 50% of patients reporting pain levels between 9-10 out of 10 during the intervention, and for pain management emergency physicians have traditionally combined local anesthetics with opioids or anxiolytics. Yet, these methods have notable drawbacks: opioids carry risks of addiction and adverse side effects (e.g., nausea/vomiting, respiratory depression, delirium), while procedural sedation is time-intensive, requires monitoring, and carries risks of complications such as apnea and hypotension.[3] Local anesthetic infiltration for pain management can also fail to effectively and evenly target the intercostal nerves responsible for chest wall sensation.[4] Ultrasound-guided fascial plane blocks (erector spinae plane and serratus plane blocks) have recently been proposed as targeted alternatives for reliable and extended pain control of tube thoracostomy as each block produces a unique distribution of anesthesia. [5] Despite establishing of these techniques for pain control during thoracic surgeries, its application in emergency settings for tube thoracostomy is underexplored enough yet [6], a gap explicitly identified in the recent literature.[4] Therefore, in this study we evaluate the impact of ESP and SAP block for pain management and overall quality of recovery which practically performed by emergency physicians.

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
Single (Participant)

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

  • Adults aged ≥18 to =<60 years presenting to the ED requiring tube thoracostomy.
  • hemodynamically stable (systolic blood pressure ≥90 mmHg).
  • Able to provide informed consent.

排除标准

  • Tension pneumothorax or hemodynamic instability requiring immediate tube insertion without time for block performance.
  • Known allergy or hypersensitivity to local anesthetics.
  • Infection or cellulitis overlying the intended needle insertion site.
  • Chronic opioid use/dependence, or substance use disorder that would confound pain and opioid-consumption outcomes.
  • Psychiatric illness, cognitive impairment, intoxication, or severe traumatic brain injury (GCS < 13) precluding reliable pain-score reporting or informed consent.
  • Body mass index ≥ 30 kg/m² (sonoanatomic landmarks less reliable).
  • Patients with spinal injury.
  • Patinets with fracture rib.

研究组 & 干预措施

SAPB

Experimental

干预措施: serratus anterior plane blocks (Procedure)

ESPB

Experimental

干预措施: Erector Spinae Plane Block (Procedure)

结局指标

主要结局

Intraprocedural pain score (NRS 0-10) recorded immediately after tube insertion and pleural fixation.

时间窗: 24 HR

次要结局

  • Total rescue opioid/sedative dose.(24 HR)
  • Time required to perform the block (needle-in to needle-out).(first 24 HR)
  • procedure-related complications (pneumothorax, hematoma, local anesthetic systemic toxicity, block failure).(first 24 HR)

研究者

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

Arwa Salah Abdelaziz Ali

arwa salah abdelaziz

Assiut University

研究点 (1)

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