About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Severe upper or lower limb trauma
Documented tourniquet use (prehospital or in-hospital)
Available documentation of tourniquet duration
Disqualifiers
Pre-existing chronic limb pain
Known severe peripheral neuropathy
Cognitive inability to complete follow-up
Expected survival <48 hours
Trial population
The study population will include adult patients (≥18 years) with severe upper or lower limb trauma who required tourniquet application for hemorrhage control in the prehospital or hospital setting. Participants will be recruited from trauma centers treating combat-related and civilian traumatic injuries. Eligible patients must have documented tourniquet use and available information on tourniquet duration. The cohort will include patients undergoing limb salvage as well as those requiring primary or secondary amputation. Participants will be followed prospectively to assess the relationship between tourniquet exposure and the development of persistent pain and functional outcomes.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Persistent Clinically Significant Pain After 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.
Secondary outcomes
Neuropathic Pain
Presence of neuropathic pain assessed using the DN4 (Douleur Neuropathique 4) questionnaire, with a score ≥4 indicating neuropathic pain.
Sponsors and contacts
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