An observational study in Polytrauma, Regional Anaesthesia and Nerve Block, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Completed at 1 site in Ukraine. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Observational
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.
Background
Regional anesthesia has become an essential component of multimodal analgesia in trauma care, providing effective pain relief, reducing opioid requirements, improving respiratory function, and facilitating early rehabilitation. Advances in ultrasound-guided techniques have enabled clinicians to perform multiple peripheral nerve blocks and continuous catheter techniques in patients with complex polytrauma involving several anatomical regions.
Despite these advantages, there is currently no evidence-based framework defining the optimal extent of regional anesthesia in polytrauma patients. In contemporary trauma practice, some patients receive one regional block, whereas others undergo multiple single-injection blocks combined with continuous peripheral nerve catheters. Although increasing the number of regional techniques may improve analgesia, excessive regional anesthesia may also increase cumulative local anesthetic exposure, procedural burden, motor impairment, monitoring complexity, and the potential risk of adverse events. The concept of an optimal "regional anesthesia burden" has not previously been investigated.
Study Rationale
This study introduces the concept of Regional Anesthesia Burden (RAB), representing the overall intensity of regional anesthesia delivered during the acute management of polytrauma. Rather than evaluating individual block techniques, the study will investigate the cumulative impact of regional anesthesia on pain control, opioid requirements, functional recovery, and early clinical outcomes.
Regional Anesthesia Burden will be characterized using objective procedural variables, including:
number of peripheral nerve blocks; number of continuous regional anesthesia catheters; cumulative local anesthetic exposure during the first 72 hours; number of anatomical regions covered by regional anesthesia; expected motor block burden; total number of regional anesthesia procedures performed.
Study Design
This is a prospective observational cohort study. Consecutive adult patients with polytrauma receiving regional anesthesia as part of routine clinical care will be enrolled. No interventions beyond standard clinical practice will be performed.
Clinical management, including the choice of regional anesthesia technique, catheter placement, local anesthetic selection, concentration, and infusion regimen, will remain entirely at the discretion of the treating anesthesiologist according to institutional protocols.
Patients will be followed prospectively during the first seven days after injury. Pain intensity, opioid consumption, respiratory function, mobilization, complications, and recovery parameters will be recorded using standardized assessment tools.
Study Objectives
The primary objective is to determine whether increasing Regional Anesthesia Burden is associated with improved early clinical outcomes or whether excessive regional anesthesia is associated with diminishing clinical benefit and increased treatment-related risk.
Secondary objectives include evaluation of the relationship between Regional Anesthesia Burden and opioid consumption, functional recovery, pulmonary complications, motor impairment, intensive care unit length of stay, hospital length of stay, and regional anesthesia-related complications.
Scientific Significance
The BLOCK-TRAUMA study is expected to provide the first prospective clinical evidence regarding the optimal extent of regional anesthesia in polytrauma patients. The results may contribute to future evidence-based recommendations regarding the appropriate use of multiple peripheral nerve blocks and continuous regional anesthesia techniques in severely injured patients and help define the balance between maximizing analgesia and minimizing procedural burden and complications.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 500 is above the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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The study population will consist of consecutive adult patients with polytrauma admitted to a Level I trauma center who receive one or more ultrasound-guided peripheral nerve blocks and/or continuous peripheral nerve catheters as part of routine multimodal pain management. Patients will be managed according to institutional trauma and regional anesthesia protocols. Prospective clinical data will be collected to evaluate the relationship between Regional Anesthesia Burden and pain control, opioid consumption, functional recovery, regional anesthesia-related complications, and early clinical outcomes during hospitalization and at 3-month follow-up.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regional Anesthesia Burden represents the cumulative extent of regional anesthesia received during the acute management of polytrauma, including the number of peripheral nerve blocks, continuous peripheral nerve catheters, cumulative local anesthetic exposure, anatomical regions treated, and procedural complexity.
Early Functional Recovery at Day 7
Early functional recovery will be assessed using the Intensive Care Unit Mobility Scale (IMS), a 0-10 scale where 0 indicates no mobility and 10 indicates independent walking, with higher scores indicating better mobility, together with successful participation in rehabilitation activities by postoperative day 7.
Time frame: Day 7 after injury
Composite Early Functional Recovery Score
Composite Early Functional Recovery Score, ranging from 0 to 2, where one point is assigned for achieving an Intensive Care Unit Mobility Scale (IMS) score ≥8 (IMS range 0-10, with higher scores indicating better mobility) and one point for successful participation in scheduled rehabilitation activities by postoperative day 7. Total scores range from 0 to 2, with higher scores indicating better early functional recovery.
Time frame: Day 7 after injury
Pain Intensity
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10).
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and Day 7 after injury.
Cumulative Local Anesthetic Dose
The cumulative dose of local anesthetic administered through all regional anesthesia techniques, including single-injection peripheral nerve blocks and continuous peripheral nerve catheter infusions, from the time of injury until Day 7. The total dose will be calculated as the sum of all local anesthetic administered and reported in milligrams (mg). Higher values indicate greater exposure to local anesthetics.
Time frame: Through Day 7 after injury.
Local Anesthetic Systemic Toxicity
Incidence of suspected or confirmed Local Anesthetic Systemic Toxicity (LAST), defined according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) criteria. Clinical features may include central nervous system manifestations (e.g., tinnitus, circumoral numbness, metallic taste, agitation, seizures, or loss of consciousness) and/or cardiovascular manifestations (e.g., arrhythmias, hypotension, cardiovascular collapse) occurring after administration of local anesthetics. Each event will be adjudicated as suspected or confirmed LAST based on clinical assessment and available diagnostic information.
Time frame: Through Day 7 after injury.
Plan to share: Yes — Access to de-identified individual participant data, the study protocol, statistical analysis plan, and supporting documentation will be provided to qualified researchers whose proposed use of the data has been approved by the principal investigator. Requests must include a methodologically sound research proposal and will require execution of a data use agreement. Data will be provided in a secure electronic format in accordance with institutional policies and applicable ethical and legal requirements.
Ran from Oct 2026 to primary completion in Oct 2026, 0 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: start Jul 2026 → Oct 2026 and primary completion Jul 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 completed, 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