Nerve BlockBRAVENCT07879508
Blast-related Regional Anaesthesia and Peripheral nerVe Injury Evaluation
A study testing Standardized Multimodal Analgesia and Ultrasound-Guided Regional Anaesthesia in people with Nerve Block and Nerve Blocks, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Nerve Block, Nerve Blocks, Nerve Injury
- What is being tested?
- Standardized Multimodal Analgesia and Ultrasound-Guided Regional Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2026to 23 Nov 2027
- Phase
- Interventional
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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: Does Regional Anaesthesia Increase Peripheral Nerve Injury After Blast Trauma? A Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Nerve Block, Nerve Blocks, Nerve Injury, Blast Injury, Combat Related Symptoms, Combat Trauma
- Being tested
- Standardized Multimodal Analgesia, Ultrasound-Guided Regional Anaesthesia
- Keywords
- Blast injury, Combat trauma, Peripheral nerve injury, Regional anaesthesia, Peripheral nerve block, Ultrasound-guided regional anaesthesia, Multimodal analgesia, Neurological outcomes
- Medical subject headings
- Blast Injuries, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Multimodal AnalgesiaDrug
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.
Ultrasound-Guided Regional AnaesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Multimodal Systemic Analgesia | Active comparator | 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. Receives: Drug: Standardized Multimodal Analgesia |
| Ultrasound-Guided Regional Anaesthesia | Experimental | Participants receive an ultrasound-guided peripheral nerve block plus standardized multimodal analgesia. Receives: Procedure: Ultrasound-Guided Regional Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after randomization
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days, 90 days, and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start23 Dec 2026 (estimated)
- Primary completion23 May 2027 (estimated)
- Study completion23 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: ultrasound-guided regional anaesthesia plus standardized multimodal analgesia, or standardized multimodal systemic analgesia without a planned nerve block. Randomization will be stratified by injured limb (upper versus lower), injury severity, and planned vascular reconstruction. Rescue analgesia, including a regional block when clinically required, will be permitted and documented.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
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
- NCT07879508
- Sponsor's protocol ID
- 0910 -012026
- Acronym
- BRAVE
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.