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临床试验/NCT07475871
NCT07475871尚未招募不适用

Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma: A Prospective Cohort Study

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Persistent Clinically Significant Pain After Limb Trauma

研究概览

简要总结

Severe limb trauma often requires the use of a tourniquet to stop life-threatening bleeding. While tourniquets are essential for saving lives, prolonged interruption of blood flow may lead to tissue ischemia, nerve injury, and inflammatory responses that could contribute to the development of chronic pain.

The TOURNI-PAIN Study is a prospective observational study designed to investigate whether the duration of tourniquet use during the treatment of severe limb injuries is associated with an increased risk of persistent pain after recovery. The study will enroll adult patients with major upper or lower limb trauma who required tourniquet application in the prehospital or hospital setting.

Researchers will collect information about the duration and characteristics of tourniquet use, details of the injury, surgical treatment, and recovery. Participants will be followed for up to 6 months after injury to assess pain levels, possible neuropathic pain, functional recovery, and quality of life.

The goal of this research is to better understand whether longer tourniquet exposure increases the risk of long-term pain. The findings may help improve trauma care practices by balancing the life-saving benefits of hemorrhage control with strategies that minimize long-term complications and improve recovery for patients with severe limb injuries.

详细描述

Severe extremity trauma is frequently associated with life-threatening hemorrhage. Tourniquet application has become a critical intervention in both military and civilian trauma systems to rapidly control bleeding and prevent exsanguination. The widespread adoption of prehospital tourniquet use has significantly improved survival in patients with major limb injuries. However, prolonged interruption of blood flow may lead to ischemia-reperfusion injury, which can affect muscles, nerves, and microvascular structures.

Experimental and clinical evidence suggests that prolonged ischemia can trigger inflammatory cascades, oxidative stress, and neural sensitization pathways that may contribute to persistent pain after trauma. Potential mechanisms include peripheral nerve ischemia, muscle necrosis, microvascular dysfunction, compartment syndrome, and systemic inflammatory activation. These processes may increase the risk of chronic pain syndromes, including neuropathic pain and, in amputees, phantom limb pain.

Despite the widespread use of tourniquets, the relationship between tourniquet duration and long-term pain outcomes after severe limb trauma has not been prospectively evaluated in large clinical cohorts. Understanding this association is important for optimizing trauma care strategies that balance the life-saving benefits of hemorrhage control with potential long-term functional and pain-related consequences.

The TOURNI-PAIN Study is a prospective observational cohort study designed to evaluate whether cumulative tourniquet exposure is associated with the development of persistent clinically significant pain after severe limb trauma. Adult patients with major upper or lower extremity injuries who required tourniquet application in the prehospital or hospital setting will be enrolled. Clinical data will be collected from medical records and structured patient assessments.

Key exposure variables will include cumulative tourniquet duration, location of application (prehospital vs. hospital), repeated applications, and total ischemia time. Additional injury-related and clinical variables such as injury severity, mechanism of injury, nerve injury, compartment syndrome, surgical procedures, transfusion requirements, and critical care parameters will also be recorded.

研究设计

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

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

  • Age ≥18 years
  • Severe upper or lower limb trauma
  • Documented tourniquet use (prehospital or in-hospital)
  • Available documentation of tourniquet duration
  • Informed consent

排除标准

  • Pre-existing chronic limb pain
  • Known severe peripheral neuropathy
  • Cognitive inability to complete follow-up
  • Expected survival <48 hours

研究组 & 干预措施

Severe Limb Trauma With Tourniquet Exposure

This cohort includes adult patients with severe upper or lower limb trauma who required tourniquet application for hemorrhage control in the prehospital or hospital setting. The study is observational and does not involve any study-mandated intervention. Clinical care will follow institutional trauma protocols. The primary exposure of interest is cumulative tourniquet duration (minutes). Participants will be followed prospectively to evaluate the association between tourniquet exposure and the development of persistent pain, neuropathic pain, functional outcomes, and quality of life up to 6 months after injury.

结局指标

主要结局

Persistent Clinically Significant Pain After Limb Trauma

时间窗: 3 and 6 months after injury

Persistent pain defined as Numeric Rating Scale (NRS) ≥4 during movement or functional activity at 3 or 6 months after injury. Pain intensity will be assessed using the standardized 0-10 Numeric Rating Scale during follow-up evaluations.

次要结局

  • Neuropathic Pain(3 and 6 months after injury)

研究者

发起方
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmytro Dmytriiev

Chief of science department, PhD, Professor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

研究点 (1)

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