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| ID | Type | Description | Link |
|---|---|---|---|
| Superhumans war trauma center | Other Identifier | Superhumans war trauma center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmytro Dmitriy Dmytriiev, PhD.Professor | Contact | +380674309449 | d.dmytriiev@superhumans.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Superhumans War Trauma Center | Lviv | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | DOI: 10.1016/j.ejvs.2014.07.002 |
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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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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D000067398 | War-Related Injuries |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D010146 | Pain |