From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma (CRA-WAR-LIMB S)

March 14, 2026 updated by: Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Lviv, Ukraine
        • Superhumans War Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • DOI: 10.1016/j.ejvs.2014.07.002

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130301032026
  • Superhumans war trauma center (Other Identifier: Superhumans war trauma center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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