Vinnitsya university hospital
Vinnytsia, 21000, Ukraine
NCT Number: NCT07702071
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Observational
Vinnytsia, 21000, Ukraine
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 7 after injury
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, 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: Baseline, 24 hours, 48 hours, 72 hours, and Day 7 after injury.
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10).
Time frame: Through Day 7 after injury.
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.
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.
Contact information is provided by the study sponsor or research team.
Ukrainian Society of Regional Anesthesia and Pain Therapy
Other
Regional Anesthesia Burden and Clinical Outcomes in Polytrauma Patients: A Prospective Cohort Study
Acronym: BLOCK-TRAUMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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