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Not Yet Recruiting NCT07879508

Blast-related Regional Anaesthesia and Peripheral nerVe Injury Evaluation

Conditions: Nerve Block, Nerve Blocks, Nerve Injury, Blast Injury, Combat Related Symptoms, Combat Trauma

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

Summary

This randomized study will examine whether ultrasound-guided regional anaesthesia (a nerve block) contributes to new or worsening peripheral nerve problems after blast-related limb trauma. Blast injuries themselves can damage nerves, making it difficult to determine whether later numbness, weakness, or neuropathic pain is caused by the injury, surgery, or the nerve block. Adults with blast-related upper- or lower-limb trauma who need pain treatment will be randomly assigned to one of two standard pain-management strategies: regional anaesthesia plus multimodal analgesia, or multimodal systemic analgesia without a planned nerve block. All participants will receive appropriate rescue pain treatment if needed. Neurological function will be documented before treatment and reassessed during hospital care and follow-up. The main outcome is a new or worsened peripheral nerve deficit 30 days after treatment. The study will also assess pain relief, opioid use, function, neuropathic pain, and safety events up to 6 months.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older. * Blast-related traumatic injury of an upper or lower limb. * Presentation within 72 hours of injury. * Acute pain requiring inpatient analgesia. * Clinically eligible for either study analgesic strategy. * Baseline motor and sensory neurological examination can be completed before randomization and, whenever feasible, before any regional anaesthesia. * Written informed consent provided by the participant or legally authorized representative, in accordance with local ethics requirements. Exclusion Criteria: * immediate clinical need for regional anaesthesia or for an alternative analgesic strategy that does not allow randomization. * Contraindication to peripheral nerve block, including infection at the injection site, clinically significant coagulopathy, or allergy to the planned local anaesthetic. * Severe traumatic brain injury, deep sedation, or other condition preventing a reliable baseline neurological examination. * Pre-existing neurological disease or peripheral neuropathy that prevents interpretation of a new limb neurological deficit. * Spinal cord injury or central neurological condition explaining the limb deficit. * Previous enrolment in this trial.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07879508). StuddyBuddy aggregates publicly available trial information.