BLOCK-TRAUMA Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Polytrauma, Regional Anaesthesia, Nerve Block, Acute Pain. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regional Anesthesia Burden and Clinical Outcomes in Polytrauma Patients: A Prospective Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Early Functional Recovery at Day 7 [Time frame: Day 7 after injury]
- Composite Early Functional Recovery Score [Time frame: Day 7 after injury]
Secondary outcome measures (3)
- Pain Intensity [Time frame: Baseline, 24 hours, 48 hours, 72 hours, and Day 7 after injury.]
- Cumulative Local Anesthetic Dose [Time frame: Through Day 7 after injury.]
- Local Anesthetic Systemic Toxicity [Time frame: Through Day 7 after injury.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ukraine · 1 center
- Vinnitsya university hospital — Vinnytsia
Publications
- Jaremko I, Lukasevic K, Tarasevicius S, Zeniauskas L, Macas A, Gelmanas A. Comparison of 2 Peripheral Nerve Blocks Techniques for Functional Recovery and Postoperative Pain Management After Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Trial. Med Sci Monit. 2021 Oct 11;27:e932848. doi: 10.12659/MSM.932848. PMID 34629461
Identifiers
NCT: NCT07702071 · 12112026-02072026