Pain ManagementCRA-WAR-LIMB SNCT07474506
From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma
An observational study of Pain Management and Perioperative Analgesia, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
To compare the effectiveness of continuous regional anaesthesia with standard pain management strategies for the treatment of acute pain in patients with war-related lower limb trauma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain Management, Perioperative Analgesia, War-Related Injuries
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Mar 2026to 15 Jun 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will include adult patients with war-related lower limb trauma who are admitted to participating trauma and rehabilitation centers and require inpatient treatment. Injuries may include blast injuries, gunshot wounds, shrapnel injuries, and other combat-related mechanisms affecting the lower extremities. Eligible patients will be those receiving pain management during hospitalization, including continuous regional anaesthesia with peripheral nerve catheters or standard multimodal analgesia. The study will include patients treated at participating institutions such as Vinnytsia National Pirogov Memorial Medical University and the Superhumans Center.
Who may be able to join
- age ≥18 years
- war-related lower limb trauma
- hospital admission requiring surgical treatment or wound management
- documented pain assessment during hospitalization
- availability of analgesic treatment data
- informed consent where required
Who cannot join
- age <18 years
- isolated upper limb trauma
- missing key pain outcome data
- contraindication to regional anaesthesia prior to treatment
- refusal to participate (for prospective component)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma - A Multicenter Comparative Cohort Study
To compare the effectiveness of continuous regional anaesthesia with standard pain management strategies for the treatment of acute pain in patients with war-related lower limb trauma.
Read the detailed description
War-related lower limb trauma represents one of the most frequent and severe injury patterns in modern armed conflicts. Blast injuries, gunshot wounds, and complex soft-tissue damage often result in severe acute pain requiring repeated surgical procedures, prolonged hospitalization, and intensive rehabilitation.
Adequate pain management in this population is critical not only for immediate patient comfort but also for facilitating wound care, early mobilization, rehabilitation participation, and potentially reducing the risk of long-term pain syndromes.
Continuous regional anaesthesia (CRA), delivered through ultrasound-guided peripheral nerve catheters, allows prolonged targeted analgesia by continuous infusion of local anesthetics. Compared with systemic analgesia or single-shot regional blocks, CRA may provide superior and sustained pain control, reduce opioid exposure, and improve rehabilitation tolerance.
However, evidence regarding the effectiveness of continuous regional anaesthesia in war-related lower limb trauma remains limited, particularly in real-world trauma settings involving blast injuries and multi-stage reconstructive surgery.
This study aims to evaluate the effectiveness and safety of continuous regional anaesthesia compared with standard analgesic strategies in patients with war-related lower limb trauma.
- Keywords
- acute pain, pain managment, analgesia, war related trauma
- Medical subject headings
- Agnosia, War-Related Injuries, Acute Pain
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 |
|---|---|---|
| Group A - Continuous Regional Anaesthesia (CRA) | atients receiving continuous peripheral nerve blockade using perineural catheters with continuous or intermittent infusion of local anesthetic. Possible catheter locations include: femoral nerve sciatic nerve popliteal sciatic nerve adductor canal fascia iliaca combined catheter techniques | |
| Group B - Standard Analgesia (Control Group) | Patients receiving standard pain management without continuous regional anaesthesia, including: systemic multimodal analgesia (opioids, NSAIDs, paracetamol, adjuvant medications) single-shot regional nerve block (if used) epidural analgesia where clinically indicated Analgesic strategy will follow standard clinical practice at each participating center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment.
Pain scores will be recorded:
at rest during movement during wound care or dressing changes.
Measured: Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.
Secondary outcomes (1)
Total opioid consumption during first 72 hours, expressed as morphine milligram equivalents (MME).
Total opioid consumption will be recorded during the first 72 hours after initiation of analgesic treatment. All administered opioids will be converted to morphine milligram equivalents (MME) using standard opioid conversion factors to allow comparison between treatment groups. The cumulative opioid dose will be calculated for each patient and analyzed as a measure of opioid requirement during the acute post-traumatic period.
Measured: Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
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 Pain ManagementStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Weeks
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
- NCT07474506
- Sponsor's protocol ID
- 130301032026
- Other IDs
- Superhumans war trauma center
- Acronym
- CRA-WAR-LIMB S
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) generated in this study will not be publicly shared due to privacy, ethical, and institutional restrictions related to sensitive clinical data from patients with war-related injuries. All data will be anonymized and used only for the purposes of the present study and related scientific publications. Aggregated results will be reported in scientific publications and presentations without disclosure of identifiable participant information.
Publications
DOI: 10.1016/j.ejvs.2014.07.002
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma - A Multicenter Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07474506
- Acronym / sponsor ID
- CRA-WAR-LIMB S / 130301032026
- Keywords
- acute pain, pain managment, analgesia, war related trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 16 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.
To compare the effectiveness of continuous regional anaesthesia with standard pain management strategies for the treatment of acute pain in patients with war-related lower limb trauma.
Detailed description
War-related lower limb trauma represents one of the most frequent and severe injury patterns in modern armed conflicts. Blast injuries, gunshot wounds, and complex soft-tissue damage often result in severe acute pain requiring repeated surgical procedures, prolonged hospitalization, and intensive rehabilitation.
Adequate pain management in this population is critical not only for immediate patient comfort but also for facilitating wound care, early mobilization, rehabilitation participation, and potentially reducing the risk of long-term pain syndromes.
Continuous regional anaesthesia (CRA), delivered through ultrasound-guided peripheral nerve catheters, allows prolonged targeted analgesia by continuous infusion of local anesthetics. Compared with systemic analgesia or single-shot regional blocks, CRA may provide superior and sustained pain control, reduce opioid exposure, and improve rehabilitation tolerance.
However, evidence regarding the effectiveness of continuous regional anaesthesia in war-related lower limb trauma remains limited, particularly in real-world trauma settings involving blast injuries and multi-stage reconstructive surgery.
This study aims to evaluate the effectiveness and safety of continuous regional anaesthesia compared with standard analgesic strategies in patients with war-related lower limb trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Continuous Regional Anaesthesia (CRA) | – | –atients receiving continuous peripheral nerve blockade using perineural catheters with continuous or intermittent infusion of local anesthetic. Possible catheter locations include: femoral nerve sciatic nerve popliteal sciatic nerve adductor canal fascia iliaca combined catheter techniques |
| Group B - Standard Analgesia (Control Group) | – | –Patients receiving standard pain management without continuous regional anaesthesia, including: systemic multimodal analgesia (opioids, NSAIDs, paracetamol, adjuvant medications) single-shot regional nerve block (if used) epidural analgesia where clinically indicated Analgesic strategy will follow standard clinical practice at each participating center. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will include adult patients with war-related lower limb trauma who are admitted to participating trauma and rehabilitation centers and require inpatient treatment. Injuries may include blast injuries, gunshot wounds, shrapnel injuries, and other combat-related mechanisms affecting the lower extremities. Eligible patients will be those receiving pain management during hospitalization, including continuous regional anaesthesia with peripheral nerve catheters or standard multimodal analgesia. The study will include patients treated at participating institutions such as Vinnytsia National Pirogov Memorial Medical University and the Superhumans Center.
Key inclusion criteria (6 listed)
- age ≥18 years
- war-related lower limb trauma
- hospital admission requiring surgical treatment or wound management
- documented pain assessment during hospitalization
- availability of analgesic treatment data
Key exclusion criteria (5 listed)
- age <18 years
- isolated upper limb trauma
- missing key pain outcome data
- contraindication to regional anaesthesia prior to treatment
- refusal to participate (for prospective component)
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
Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment.
Time frame: Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.
Pain scores will be recorded: at rest during movement during wound care or dressing changes.
1 secondary outcome
Total opioid consumption during first 72 hours, expressed as morphine milligram equivalents (MME).
Time frame: Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- BackgroundDOI: 10.1016/j.ejvs.2014.07.002
- Individual participant dataSharing planned: No. Individual participant data (IPD) generated in this study will not be publicly shared due to privacy, ethical, and institutional restrictions related to sensitive clinical data from patients with war-related injuries. All data will be anonymized and used only for the purposes of the present study and related scientific publications. Aggregated results will be reported in scientific publications and presentations without disclosure of identifiable participant information.
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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.
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 Management and Perioperative Analgesia, 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmitriy Dmytriiev, PhD.Professor (+380674309449, d.dmytriiev@superhumans.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment. (time frame: Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.). 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 NCT07474506, 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 17 Mar 2026.