NCT07868133

Brief Summary

This study will examine nerve problems after combat-related injuries to the arms or legs. Some patients receive a peripheral nerve block, an injection of local anaesthetic near a nerve, to help control pain. However, combat injuries themselves can damage nerves through blast effects, fractures, blood vessel injury, bleeding, infection, surgery, or use of a tourniquet. The study will follow adults with combat-related limb injuries who receive routine care at a specialised trauma centre. Treatment will not be assigned by the study. Researchers will record details of the injury, pain treatment, nerve block use, and nerve function over time. The main goal is to determine how often patients have new or worsened numbness, weakness, or nerve pain after injury, and whether these problems are more closely related to the injury itself, the nerve block, or several factors together. The findings may help clinicians provide safer pain treatment and recognise nerve problems earlier.

Trial Health

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Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Oct 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

Same day

First QC Date

September 30, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Peripheral nerve block;Regional anaesthesiaCombat traumaPeripheral nerve injuryNeurological complicationsLimb traumaUltrasound-guided regional anaesthesiaPain management

Outcome Measures

Primary Outcomes (1)

  • Number of participants with persistent peripheral neurological deficit at 90 days after injury

    Persistent peripheral neurological deficit will be assessed at 90 days after injury by clinical neurological examination and documented as present or absent, including sensory loss, motor weakness, or neuropathic symptoms attributable to peripheral nerve injury.

    Mean Medical Research Council (MRC) muscle strength score at 90 days after injury

Secondary Outcomes (4)

  • Number of participants with early peripheral neurological deficit within 72 hours after injury

    48 to 72 hours after the index injury.

  • Pain Intensity

    48 to 72 hours and 90 days after the index injury.

  • Attribution of Persistent Neurological Deficit

    90 days after the index injury.

  • Number of participants with a regional anaesthesia-related safety event within 48 hours after block placement

    From peripheral nerve block placement to 72 hours after the index injury.

Study Arms (1)

Peripheral Nerve Block Group

Adults with combat-related upper- or lower-limb trauma who received an ultrasound-guided peripheral nerve block as part of routine clinical care. Blocks may be single-injection techniques or continuous peripheral nerve catheters. The study does not assign the block or modify clinical treatment; it records routinely delivered analgesia and subsequent neurological outcomes.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with combat-related upper- or lower-limb trauma treated at a specialised Ukrainian war trauma centre. The population includes patients with blast- or ballistic-related injuries, fractures, soft-tissue injury, vascular injury, traumatic amputation, or complex reconstructive needs. Patients may receive ultrasound-guided peripheral nerve blocks or routine non-regional analgesia as part of standard clinical care.

You may qualify if:

  • Adults aged 18 years or older.
  • Combat-related traumatic injury of an upper or lower limb, including blast- or ballistic-related injury.
  • Admission to, or treatment at, the study centre during the defined study period.
  • Available clinical documentation of injury characteristics and neurological assessment sufficient for outcome evaluation.
  • Receipt of routine trauma care with or without an ultrasound-guided peripheral nerve block.

You may not qualify if:

  • Pre-existing neurological disease or documented chronic peripheral neuropathy that prevents reliable assessment of a new trauma-related neurological deficit.
  • Isolated injuries without involvement of an upper or lower limb.
  • Missing or insufficient medical-record data on injury characteristics, analgesia exposure, or neurological outcome.
  • Death before neurological outcome assessment.
  • Withdrawal of consent, where consent is required by the ethics committee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Nerve InjuriesAgnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dmyto Dmytriiev, PhD.Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, head of intensive care department

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study includes sensitive clinical and conflict-related information. Protecting participant confidentiality and operational security is essential. De-identified aggregate results may be available in publications and, where appropriate, further information may be considered after ethics and data-governance review.