PolytraumaBLOCK-TRAUMANCT07702071
BLOCK-TRAUMA Study
An observational study of Polytrauma and Regional Anaesthesia, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Polytrauma, Regional Anaesthesia, Nerve Block
- How many people
- 500 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Oct 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia Burden and Clinical Outcomes in Polytrauma Patients: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Polytrauma, Regional Anaesthesia, Nerve Block, Acute Pain, Combat Trauma
- Keywords
- Polytrauma, Regional Anesthesia, Peripheral Nerve Block, Acute Pain, Local Anesthetics, Combat Injury
- Medical subject headings
- Multiple Trauma, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Regional Anesthesia Burden | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 7 after injury
Secondary outcomes (3)
Pain Intensity
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10).
Measured: 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.
Measured: 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.
Measured: Through Day 7 after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
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
- NCT07702071
- Sponsor's protocol ID
- 12112026-02072026
- Acronym
- BLOCK-TRAUMA
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 34629461
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia Burden and Clinical Outcomes in Polytrauma Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07702071
- Acronym / sponsor ID
- BLOCK-TRAUMA / 12112026-02072026
- Conditions
- Polytrauma, Regional Anaesthesia, Nerve Block, Acute Pain, Combat Trauma
- Keywords
- Polytrauma, Regional Anesthesia, Peripheral Nerve Block, Acute Pain, Local Anesthetics, Combat Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia Burden | – | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Functional Recovery at Day 7
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.
Composite Early Functional Recovery Score
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.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 34629461Jaremko 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polytrauma and Regional Anaesthesia, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Functional Recovery at Day 7 (time frame: Day 7 after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07702071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.