Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Severe Limb Trauma With Tourniquet Exposure

Trial outcomes

Primary outcomes

1

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.

Time frame
3 and 6 months after injury

Secondary outcomes

1

Neuropathic Pain

Presence of neuropathic pain assessed using the DN4 (Douleur Neuropathique 4) questionnaire, with a score ≥4 indicating neuropathic pain.

Time frame
3 and 6 months after injury

Other outcomes

Sponsors and contacts

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