NCT07474506

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

acute painpain managmentanalgesiawar related trauma

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Total opioid consumption during first 72 hours, expressed as morphine milligram equivalents (MME).

    Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

  • DOI: 10.1016/j.ejvs.2014.07.002

    BACKGROUND

MeSH Terms

Conditions

AgnosiaWar-Related InjuriesAcute Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesPain

Central Study Contacts

Dmytro Dmitriy Dmytriiev, PhD.Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

March 15, 2026

Primary Completion

June 15, 2026

Study Completion

June 15, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations