PainTOURNI-PAINNCT07475871
Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma
An observational study of Pain and Pain After Surgery, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Pain After Surgery, Phantom Limb Pain After Amputation
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Mar 2026to 15 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- Age ≥18 years
- Severe upper or lower limb trauma
- Documented tourniquet use (prehospital or in-hospital)
- Available documentation of tourniquet duration
- Informed consent
Who cannot join
- Pre-existing chronic limb pain
- Known severe peripheral neuropathy
- Cognitive inability to complete follow-up
- Expected survival <48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma: A Prospective Cohort Study
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.
Read more
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.
Read the detailed description
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.
Participants will be followed for up to six months after injury. Pain outcomes will be evaluated using standardized measures including the Numeric Rating Scale (NRS) for pain intensity, the DN4 questionnaire for neuropathic pain, and the Brief Pain Inventory for pain interference. Additional outcomes will include opioid consumption, functional recovery, and health-related quality of life.
The primary objective is to determine whether prolonged tourniquet exposure is independently associated with persistent clinically significant pain at 3 or 6 months after injury. Secondary analyses will explore dose-response relationships between ischemia duration and pain outcomes, as well as interactions between tourniquet exposure and clinical factors such as amputation, compartment syndrome, and nerve injury.
The results of this study may help inform trauma care guidelines by providing evidence on the potential long-term consequences of prolonged tourniquet use and by identifying modifiable risk factors for chronic pain after severe limb trauma.
- Conditions
- Pain, Pain After Surgery, Phantom Limb Pain After Amputation, Military Combat Stress Reaction
- Keywords
- Tourniquet, Chronic Pain, Phantom Limb Pain, Trauma Rehabilitation
- Medical subject headings
- Pain, Chronic Pain, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 and 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475871
- Sponsor's protocol ID
- 130302032026
- Other IDs
- Superhumans war trauma center
- Acronym
- TOURNI-PAIN
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to ethical, legal, and security considerations related to sensitive clinical data from trauma patients, including those with combat-related injuries. Data may contain potentially identifiable health information and details associated with military trauma. De-identified aggregated data may be shared upon reasonable request and subject to approval by the study investigators and institutional ethics committees, in accordance with institutional policies and applicable data protection regulations.
Publications
Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Practical use of emergency tourniquets to stop bleeding in major limb trauma. J Trauma. 2008 Feb;64(2 Suppl):S38-49; discussion S49-50. doi: 10.1097/TA.0b013e31816086b1.
PubMed 18376170
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07475871
- Acronym / sponsor ID
- TOURNI-PAIN / 130302032026
- Conditions
- Pain, Pain After Surgery, Phantom Limb Pain After Amputation, Military Combat Stress Reaction
- Keywords
- Tourniquet, Chronic Pain, Phantom Limb Pain, Trauma Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants will be followed for up to six months after injury. Pain outcomes will be evaluated using standardized measures including the Numeric Rating Scale (NRS) for pain intensity, the DN4 questionnaire for neuropathic pain, and the Brief Pain Inventory for pain interference. Additional outcomes will include opioid consumption, functional recovery, and health-related quality of life.
The primary objective is to determine whether prolonged tourniquet exposure is independently associated with persistent clinically significant pain at 3 or 6 months after injury. Secondary analyses will explore dose-response relationships between ischemia duration and pain outcomes, as well as interactions between tourniquet exposure and clinical factors such as amputation, compartment syndrome, and nerve injury.
The results of this study may help inform trauma care guidelines by providing evidence on the potential long-term consequences of prolonged tourniquet use and by identifying modifiable risk factors for chronic pain after severe limb trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Severe upper or lower limb trauma
- Documented tourniquet use (prehospital or in-hospital)
- Available documentation of tourniquet duration
- Informed consent
Key exclusion criteria (4 listed)
- Pre-existing chronic limb pain
- Known severe peripheral neuropathy
- Cognitive inability to complete follow-up
- Expected survival <48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistent Clinically Significant Pain After Limb Trauma
Time frame: 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.
1 secondary outcome
Neuropathic Pain
Time frame: 3 and 6 months after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 18376170Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Practical use of emergency tourniquets to stop bleeding in major limb trauma. J Trauma. 2008 Feb;64(2 Suppl):S38-49; discussion S49-50. doi: 10.1097/TA.0b013e31816086b1.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to ethical, legal, and security considerations related to sensitive clinical data from trauma patients, including those with combat-related injuries. Data may contain potentially identifiable health information and details associated with military trauma. De-identified aggregated data may be shared upon reasonable request and subject to approval by the study investigators and institutional ethics committees, in accordance with institutional policies and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pain After Surgery, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Clinically Significant Pain After Limb Trauma (time frame: 3 and 6 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.