Major limb trauma is associated with a high risk of venous thromboembolism (VTE) due to systemic inflammation, endothelial injury, immobilization, and hypercoagulability. While VTE is commonly studied as a short-term complication affecting morbidity and mortality, its potential relationship with long-term pain outcomes after trauma has not been well investigated.
This prospective observational cohort study aims to evaluate whether objectively confirmed VTE is associated with an increased risk of persistent clinically significant pain after major limb trauma. Adult patients with severe upper or lower limb injuries requiring surgical treatment or prolonged immobilization will be enrolled within 72 hours of hospital admission and followed for six months.
The study will assess whether patients who develop VTE have a higher likelihood of persistent pain compared with those without VTE. In addition, the study will explore the association between baseline VTE risk (using the Trauma Embolic Scoring System, TESS), thromboprophylaxis timing, and long-term pain outcomes. Secondary analyses will evaluate neuropathic pain symptoms, pain interference with daily activities, quality of life, opioid consumption, and functional recovery.
Understanding the relationship between thromboembolic complications and persistent pain may help improve risk stratification, optimize thromboprophylaxis strategies, and support early rehabilitation planning in patients with major limb trauma.
Age ≥18 years
Major upper or lower limb trauma
Surgical treatment and/or immobilization ≥72 hours
Enrollment within 72 hours of admission
Pre-existing chronic pain unrelated to trauma (investigator judgment)
Therapeutic anticoagulation prior to trauma
Cognitive inability to complete follow-up
Expected survival <48 hours
The study population will include adult patients (≥18 years) with major upper or lower limb trauma requiring surgical treatment and/or prolonged immobilization (≥72 hours). Participants will be recruited from trauma centers managing severe civilian and combat-related injuries. Eligible patients will be enrolled within 72 hours of hospital admission. The cohort will include patients with various mechanisms of injury, including blast injuries, fragmentation injuries, gunshot wounds, and other high-energy trauma. Participants will be followed prospectively for up to 6 months to evaluate the association between venous thromboembolism (VTE) and the development of persistent post-traumatic pain.
Cohort
Retrospective
Not listed
Persistent Clinically Significant Pain After Major Limb Trauma
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.
Neuropathic Pain
DN4 (Douleur Neuropathique 4 Questionnaire) will be used to assess neuropathic pain. The DN4 score ranges from 0 to 10, where higher scores indicate a greater likelihood of neuropathic pain. A score of ≥4 is considered indicative of neuropathic pain.
Opioid Consumption
Total opioid consumption during follow-up expressed as oral morphine equivalent dose (OME/day).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
