An interventional study of Standardized Multimodal Analgesia and Ultrasound-Guided Regional Anaesthesia in Nerve Block, Nerve Blocks and Nerve Injury, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
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.
Blast-related limb trauma can cause peripheral nerve injury through direct tissue disruption, fracture, vascular injury, haemorrhage, compression, surgery, and tourniquet use. Because regional anaesthesia is often introduced after injury, neurological symptoms observed after a nerve block may be incorrectly attributed to the block rather than to trauma-related or perioperative factors. High-quality prospective evidence is needed to quantify the incremental neurological risk, if any, associated with regional anaesthesia in this setting.
The BRAVE trial is a pragmatic, randomized, assessor-blinded safety study in adults with blast-related upper- or lower-limb trauma. Participants will be allocated to ultrasound-guided regional anaesthesia with standardized multimodal analgesia or to standardized multimodal systemic analgesia without a planned nerve block. Rescue analgesia, including regional anaesthesia when clinically necessary, will be available and documented.
A structured bilateral neurological examination will be completed before allocation and before any nerve block whenever clinically feasible. Injury characteristics, surgical procedures, vascular reconstruction, tourniquet exposure, fracture displacement, haematoma, and other potential causes of nerve dysfunction will be recorded. Follow-up neurological assessments will be performed using a prespecified schedule. Persistent, severe, progressive, or anatomically unexplained deficits will undergo specialist evaluation and appropriate electrodiagnostic and/or imaging investigations.
An independent outcome assessor, unaware of treatment allocation, will evaluate neurological outcomes. A blinded adjudication process will classify neurological deficits as likely trauma-related, procedure-related, multifactorial, or indeterminate. The study is designed to support safer analgesic decision-making after blast trauma while preserving access to effective rescue pain treatment.
91 studies on the registry are indexed under Peripheral Nerve Injuries; 22 are open to participants now.
This study's planned enrollment of 150 is above the median of 44 across 61 interventional studies indexed under Peripheral Nerve Injuries.
Browse Peripheral Nerve Injuries studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 14 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants receive standardized multimodal systemic analgesia without a planned peripheral nerve block. A rescue nerve block is permitted when clinically necessary and will be recorded.
Drug: Standardized Multimodal Analgesia
Participants receive an ultrasound-guided peripheral nerve block plus standardized multimodal analgesia.
Procedure: Ultrasound-Guided Regional Anaesthesia
Participants receive standardized multimodal systemic analgesia without a planned peripheral nerve block. A rescue nerve block is permitted when clinically necessary and will be documented.
Participants will receive an ultrasound-guided peripheral nerve block targeting the nerve or plexus supplying the injured limb. The block technique, local anaesthetic agent, concentration, volume, and use of a single-injection or continuous catheter technique will be selected by the treating anaesthesiologist according to the anatomical site of injury, surgical plan, and study protocol. All procedures will be performed by trained clinicians using ultrasound guidance and documented in the case-report form, including block location, timing, technical events, and local anaesthetic dose. Standardized multimodal analgesia will be provided in addition to the block.
New or Worsened Peripheral Nerve Deficit at 30 Days
Peripheral nerve function will be assessed before randomization and at 30 days using a standardized bilateral neurological examination. Motor function will be graded with the Medical Research Council (MRC) scale (0-5) in muscle groups corresponding to the injured limb and relevant peripheral nerves. Sensory function will be mapped in predefined nerve territories using light touch and pinprick and graded as 0 = absent, 1 = reduced/abnormal, or 2 = normal. New neuropathic symptoms, including numbness, tingling, burning pain, or allodynia, will also be documented. A primary outcome event is defined as a new sensory or motor deficit, or worsening of a pre-existing deficit, compared with the pre-randomization examination. Persistent, severe, progressive, or anatomically unexplained deficits will undergo neurological consultation and, when clinically indicated, nerve conduction studies/electromyography and/or ultrasound or MRI. Final outcome classification will be made by independent assess
Time frame: 30 days after randomization
Acute Pain Intensity
Pain at rest and during movement measured on an 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain).
Time frame: Baseline; 6, 24, 48, and 72 hours after randomization
Persistent Peripheral Nerve Deficit
Persistent peripheral nerve deficit will be measured by comparing standardized neurological examinations at 90 days and 6 months with the pre-randomization examination. Motor function will be assessed using the Medical Research Council (MRC) scale (0-5) in relevant muscle groups. Sensory function will be assessed in predefined peripheral nerve territories using light touch and pinprick and graded as 0 = absent, 1 = reduced/abnormal, or 2 = normal. A persistent deficit is defined as a sensory and/or motor abnormality that is new or worse than baseline and remains present at the follow-up assessment. Participants with a persistent, progressive, or clinically significant deficit will undergo neurological review and, when clinically indicated, nerve conduction studies/electromyography and/or ultrasound or MRI.
Time frame: 90 days and 6 months after randomization
Neuropathic Pain
Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The DN4 score ranges from 0 to 10; a score of 4 or higher will be considered consistent with neuropathic pain. Pain intensity will be measured using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at rest and during movement. The location and distribution of pain will be recorded and compared with the anatomical distribution of the traumatic injury and any neurological deficit.
Time frame: 30 days, 90 days, and 6 months after randomization
Limb Function
Limb function and pain-related functional interference will be assessed using the Brief Pain Inventory-Interference subscale (BPI-I). Participants rate how much pain interferes with seven domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 to 10, where 0 indicates no interference and 10 indicates complete interference. The mean BPI-I score will be calculated when sufficient items are completed; higher scores indicate greater pain-related functional limitation. For participants with lower-limb injury, mobility status and ability to bear weight or use a prosthesis, where applicable, will also be recorded.
Time frame: 30 days, 90 days, and 6 months after randomization
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying the published results, together with the study protocol, statistical analysis plan, and data dictionary, will be available to qualified researchers upon reasonable request. Data will be shared only after approval by the study team and relevant ethics and data-governance bodies, and after execution of a data-sharing agreement. No directly identifying information will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the primary results and ending 5 years after publication.
Access criteria: Proposals should include a methodologically sound research question and analysis plan. Requests will be reviewed by the study steering committee.
Data sharing details ↗ · uaratb.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2027, 5 months later.
Of 22 interventional studies with no phase under Peripheral Nerve Injuries, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ukrainian Society of Regional Anesthesia and Pain Therapy