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临床试验/NCT07308587
NCT07308587招募中不适用

Prospective Evaluation of Intercostal Neuralgia Incidence, Risk Factors, and Outcomes in Patients With Chest Tube Insertion After Traumatic Rib Fractures

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Incidence of intercostal neuralgia

研究概览

简要总结

Traumatic rib fractures are common injuries following blunt chest trauma, often requiring chest tube insertion to manage complications such as pneumothorax or haemothorax. However, chest tube placement can lead to intercostal nerve injury, resulting in intercostal neuralgia-a debilitating condition characterized by chronic, neuropathic pain along the intercostal nerves. Despite its clinical significance, the incidence, risk factors, and long-term outcomes of intercostal neuralgia in this patient population remain poorly understood.

Chronic pain following thoracic trauma, including intercostal neuralgia, has been shown to significantly impair quality of life and functional outcomes, leading to prolonged disability and increased healthcare utilization. Current literature highlights the need for better understanding and management of this condition, particularly in patients undergoing invasive procedures such as chest tube insertion. This study aims to prospectively evaluate the development of intercostal neuralgia in patients with chest tube insertion following traumatic rib fractures.

详细描述

Intercostal neuralgia is defined as pain along the intercostal nerve distribution with neuropathic features. Chronic intercostal neuralgia is defined as having intercostal neuralgia symptoms for >3 months.

Intercostal neuralgia pain will be specifically differentiated from persistent rib fracture pain through the presence of neuropathic pain at the level of the chest tube/pigtail that is reproducible with brushing/light touch to the chest tube scar site.

The following data will be collected:

Baseline:

  • Demographic information (age, sex, ethnicity, comorbidities).
  • Pain assessment using numerical rating scale at rest and with deep inspiration
  • Pre-existing chronic pain conditions (e.g., fibromyalgia, chronic regional pain syndrome) and history of prior thoracic surgery or chest tube insertion.
  • Injury characteristics (mechanism of injury including presence of foreign bodies and additional penetrating injuries, number and location of rib fractures, associated injuries including vertebral body fractures, sternal fracture, transverse process fracture).
  • Neurologic assessment (Glasgow Coma Scale [GCS] on presentation and at time of recruitment)
  • Brain imaging findings on presentation (if applicable)
  • Chest tube / pigtail details (size, insertion site, duration of placement).
  • Spirometry testing including forced vital capacity (FVC) and forced expiratory volume (FEV1) at time of enrolment of study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adults (≥18 years) with traumatic rib fractures requiring chest tube insertion
  • Chest tube or pigtail insertion performed during their initial hospitalization for trauma

排除标准

  • Patients with spinal cord injury
  • Inability to complete follow-up assessments (e.g., language barriers, lack of telephone access)
  • Exclusion Criteria:
  • Patients with traumatic brain injury
  • Patients with spinal cord injury
  • Inability to complete follow-up assessments (e.g., language barriers, lack of telephone access)

结局指标

主要结局

Incidence of intercostal neuralgia

时间窗: 1 and 3 months

To determine the incidence of intercostal neuralgia in patients undergoing chest tube insertion after traumatic rib fractures. Presence of neuropathic pain to be assessed using S-LANSS (score of 12 or more suggests pain of predominantly neuropathic origin)

次要结局

  • Assess the impact of intercostal neuralgia on quality of life and functional outcomes(1 and 3 months)
  • Assess the impact of intercostal neuralgia on medication use(1 and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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