Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma

NCT07475871 | Not Yet Recruiting

• 2 other identifiers: 130302032026Superhumans war trauma center
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Pain After Surgery; Phantom Limb Pain After Amputation; Military Combat Stress Reaction

Keywords

Tourniquet; Chronic Pain; Phantom Limb Pain; Trauma Rehabilitation

Outcome Measures

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.

  3 and 6 months after injury

Secondary Outcomes (1)

• Neuropathic Pain

  3 and 6 months after injury

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 18376170 RESULT

MeSH Terms

Conditions

Pain; Chronic Pain; Phantom Limb

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Central Study Contacts

Dmytro Dmitriy Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of science department, PhD, Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)