Combat-Related Limb InjuryNERVE-COMBATNCT07868133
Nerve Blocks or Combat Trauma: What Drives Peripheral Nerve Injury?
An observational study of Combat-Related Limb Injury and Nerve Block, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Combat-Related Limb Injury, Nerve Block, Nerve Damage
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Oct 2026
- How long will I take part?
- 3 Months
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nerve Blocks or Combat Trauma: What Drives Peripheral Nerve Injury? A Prospective Observational Cohort Study
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.
Read the detailed description
Combat-related limb trauma is frequently accompanied by peripheral nerve injury. Neurological symptoms identified after trauma may result from the original injury, blast effects, fractures, vascular compromise, tourniquet exposure, haematoma, infection, surgery, or pain treatment. Peripheral nerve blocks are commonly used for analgesia, but determining whether a later neurological deficit is related to the block, the injury, or multiple factors is often difficult.
This prospective observational cohort study will collect routine clinical data from adults with combat-related upper- or lower-limb trauma. The study will not assign or alter treatment. Peripheral nerve blocks, surgical care, imaging, rehabilitation, and pharmacological analgesia will be provided according to clinical need and local practice.
Investigators will document injury characteristics, neurological findings before and after analgesia when feasible, regional anaesthesia details, pain outcomes, relevant imaging and follow-up neurological status. Participants with a persistent or worsening neurological deficit will undergo structured multidisciplinary case review. Events will be classified as trauma-associated, possibly block-associated, multifactorial, or indeterminate.
The study aims to describe neurological outcomes after combat limb trauma and identify factors associated with persistent deficits. The findings may support safer regional anaesthesia practice, improve documentation of baseline nerve function, and strengthen pathways for early recognition and referral of peripheral nerve injury.
- Conditions
- Combat-Related Limb Injury, Nerve Block, Nerve Damage, Nerve Blocks, Neurological Complications
- Keywords
- Peripheral nerve block;, Regional anaesthesia, Combat trauma, Peripheral nerve injury, Neurological complications, Limb trauma, Ultrasound-guided regional anaesthesia, Pain management
- Medical subject headings
- Peripheral Nerve Injuries, Agnosia
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Early peripheral neurological deficit will be assessed within 72 hours after injury by clinical neurological examination and recorded as present or absent. Deficit includes sensory loss, motor weakness, or neuropathic symptoms consistent with peripheral nerve injury.
Measured: 48 to 72 hours after the index injury.
Pain Intensity
Pain intensity at rest and during movement measured on the 0-10 Numeric Rating Scale.
Measured: 48 to 72 hours and 90 days after the index injury.
Attribution of Persistent Neurological Deficit
Multidisciplinary classification of persistent neurological deficits as trauma-associated, possibly peripheral nerve block-associated, multifactorial, or indeterminate.
Measured: 90 days after the index injury.
Number of participants with a regional anaesthesia-related safety event within 48 hours after block placement
Regional anaesthesia-related safety events will be recorded from block placement until 48 hours afterwards and reported as present or absent. Events include local anaesthetic systemic toxicity, clinically significant bleeding or haematoma, infection, persistent paraesthesia or motor deficit, nerve injury, vascular puncture, pneumothorax, or unplanned escalation of care attributable to the procedure.
Measured: From peripheral nerve block placement to 72 hours after the index injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combat-Related Limb InjuryStudies 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
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868133
- Sponsor's protocol ID
- NBT-PNI-2026-01
- Acronym
- NERVE-COMBAT
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Blocks or Combat Trauma: What Drives Peripheral Nerve Injury? A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07868133
- Acronym / sponsor ID
- NERVE-COMBAT / NBT-PNI-2026-01
- Conditions
- Combat-Related Limb Injury, Nerve Block, Nerve Damage, Nerve Blocks, Neurological Complications
- Keywords
- Peripheral nerve block;, Regional anaesthesia, Combat trauma, Peripheral nerve injury, Neurological complications, Limb trauma, Ultrasound-guided regional anaesthesia, Pain management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Oct 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.
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.
Detailed description
Combat-related limb trauma is frequently accompanied by peripheral nerve injury. Neurological symptoms identified after trauma may result from the original injury, blast effects, fractures, vascular compromise, tourniquet exposure, haematoma, infection, surgery, or pain treatment. Peripheral nerve blocks are commonly used for analgesia, but determining whether a later neurological deficit is related to the block, the injury, or multiple factors is often difficult.
This prospective observational cohort study will collect routine clinical data from adults with combat-related upper- or lower-limb trauma. The study will not assign or alter treatment. Peripheral nerve blocks, surgical care, imaging, rehabilitation, and pharmacological analgesia will be provided according to clinical need and local practice.
Investigators will document injury characteristics, neurological findings before and after analgesia when feasible, regional anaesthesia details, pain outcomes, relevant imaging and follow-up neurological status. Participants with a persistent or worsening neurological deficit will undergo structured multidisciplinary case review. Events will be classified as trauma-associated, possibly block-associated, multifactorial, or indeterminate.
The study aims to describe neurological outcomes after combat limb trauma and identify factors associated with persistent deficits. The findings may support safer regional anaesthesia practice, improve documentation of baseline nerve function, and strengthen pathways for early recognition and referral of peripheral nerve injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Number of participants with persistent peripheral neurological deficit at 90 days after injury
Time frame: Mean Medical Research Council (MRC) muscle strength score 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.
4 secondary outcomes
Number of participants with early peripheral neurological deficit within 72 hours after injury
Time frame: 48 to 72 hours after the index injury.
Pain Intensity
Time frame: 48 to 72 hours and 90 days after the index injury.
Attribution of Persistent Neurological Deficit
Time frame: 90 days after the index injury.
Number of participants with a regional anaesthesia-related safety event within 48 hours after block placement
Time frame: From peripheral nerve block placement to 72 hours after the index injury.
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 9 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Acute Post-Amputation Pain Management After Combat-Related Lower Limb Injury
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Combat-Related Limb Injury and Nerve Block, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
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 5 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dmyto Dmytriiev, PhD.Professor (0674309449, dmytrodmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with persistent peripheral neurological deficit at 90 days after injury (time frame: Mean Medical Research Council (MRC) muscle strength score at 90 days after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.