BLOCK-TRAUMA Study (NCT07702071) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BLOCK-TRAUMA Study
Ukraine500 participantsStarted 2026-07-23
Plain-language summary
This prospective cohort study will evaluate the association between the overall burden of regional anesthesia and early clinical outcomes in adult patients with polytrauma.
Patients with severe trauma often experience pain from multiple injury sites and may require more than one peripheral nerve block or continuous regional anesthesia catheter. While regional anesthesia can improve pain control and reduce opioid use, multiple blocks and catheters may also increase treatment complexity, local anesthetic exposure, motor weakness, and monitoring challenges.
The study will prospectively collect data on the number and type of regional anesthesia procedures, local anesthetic exposure, catheter use, pain intensity, opioid consumption, mobility, complications, and early recovery outcomes. The goal is to determine whether increasing regional anesthesia burden is associated with improved analgesia, functional recovery, or increased risk in polytrauma patients.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Diagnosis of polytrauma, defined as traumatic injuries involving two or more anatomical regions.
* Injury Severity Score (ISS) ≥16.
* Hospital admission within 48 hours after injury.
* Requirement for acute pain management during hospital treatment.
* Receipt of at least one ultrasound-guided peripheral nerve block and/or continuous peripheral nerve catheter as part of routine clinical care.
* Ability to collect clinical data on regional anesthesia procedures, analgesic use, pain assessment, and early recovery outcomes.
* Written informed consent provided by the patient or legally authorized representative, according to local regulations.
Exclusion Criteria:
* Age younger than 18 years.
* Isolated single-system injury without polytrauma. ISS \<16.
* Expected survival less than 24 hours after admission.
* Severe traumatic brain injury or impaired consciousness preventing reliable pain and functional assessment, unless validated behavioral pain scales can be used.
* Known allergy or contraindication to local anesthetics.
* Pre-existing severe neuromuscular disease affecting motor function assessment.
* Chronic opioid therapy before injury.
* Pregnancy.
* Enrollment in another interventional trial that may affect pain management or functional recovery outcomes.
* Missing essential data required for assessment of Regional Anesthesia Burden.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Functional Recovery at Day 7
Timeframe: Day 7 after injury
2
Composite Early Functional Recovery Score
Timeframe: Day 7 after injury
Trial details
NCT IDNCT07702071
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy