Nerve Blocks or Combat Trauma: What Drives Peripheral Nerve Injury?
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Peripheral Nerve Block Group
Trial outcomes
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.
Time frame
Mean Medical Research Council (MRC) muscle strength score at 90 days after injurySecondary outcomes
1
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.
Time frame
48 to 72 hours after the index injury.2
Pain Intensity
Pain intensity at rest and during movement measured on the 0-10 Numeric Rating Scale.
Time frame
48 to 72 hours and 90 days after the index injury.3
Attribution of Persistent Neurological Deficit
Multidisciplinary classification of persistent neurological deficits as trauma-associated, possibly peripheral nerve block-associated, multifactorial, or indeterminate.
Time frame
90 days after the index injury.4
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.
Time frame
From peripheral nerve block placement to 72 hours after the index injury.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: