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临床试验/NCT05105399
NCT05105399尚未招募不适用

Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures: a Perspective Randomized Controlled Study

Niguarda Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026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
72
试验地点
2
主要终点
FEV1 (% of the predicted value)

研究概览

简要总结

In patients admitted following a trauma, the incidence of multiple rib fractures is reported to be 9,7%, and this can be even higher in high energy trauma like motor vehicle accidents (1). Pain deriving from rib fractures cause the patient to breath shallow in order to limit discomfort and this bring about negative consequences: shallow breathing and inability to clear secretions may cause pulmonary atelectasis eventually evolving to pneumonia. Given the aforementioned concerns, it is easy to understand why, in a context like this, control of chest pain become crucial. The best way to achieve adequate pain control have not yet been established: the aim of this study is to investigate on this clinical dilemma. In this study, 72 people with at least two monolateral rib fractures are going to be randomized into three groups: 1) standard treatment alone (intravenous analgesia: acetaminophen + morphine PCA); 2) continuous serratus plane block + standard treatment; 3) single-shot serratus plane block + standard treatment. The variables that are going to be recorded are the following: pain through the NRS scale, FEV1 and FVC through spirometry and finally an arterious gas analysis. Recording are going to be repeated at 72h after admission. The primary endpoint is to evaluate if the continuous serratus plane block is able to improve the FEV1/FVC compared to single shot or standard treatment alone. Secondary endpoints will be: the effect of continuous block on 1) resting and incident pain; 2) opioid consumption; 3) blood gas analysis parameters; 4) pulmonary complications at 1 month; 5) length of stay

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Chest trauma with at least 2 monolateral rib fractures (monofocal or multifocal) with no flail chest
  • Age>18 years
  • Hospital admission
  • Ability to provide written informed consensus
  • Awake patient, spontaneous ventilation

排除标准

  • 未提供

研究组 & 干预措施

Morphine

No Intervention

Continuous

Active Comparator

干预措施: Serratus plane block (continuous or single-shot) (Procedure)

Single

Active Comparator

干预措施: Serratus plane block (continuous or single-shot) (Procedure)

结局指标

主要结局

FEV1 (% of the predicted value)

时间窗: 72 hours

Any statistically significant difference between the two treatment groups and the control group will be measured. FEV1 is expected to be respectively 80±15% of the predicted value in the treatment groups and 64±15% of the predicted value in the control group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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