BLOCK-TRAUMA Study

NCT07702071 | Not Yet Recruiting

• 1 other identifier: 12112026-02072026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polytrauma; Regional Anaesthesia; Nerve Block; Acute Pain; Combat Trauma

Keywords

Polytrauma; Regional Anesthesia; Peripheral Nerve Block; Acute Pain; Local Anesthetics; Combat Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 7 after injury

Secondary Outcomes (3)

• Pain Intensity

  Baseline, 24 hours, 48 hours, 72 hours, and Day 7 after injury.

• Cumulative Local Anesthetic Dose

  Through Day 7 after injury.

• Local Anesthetic Systemic Toxicity

  Through Day 7 after injury.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Vinnitsya university hospital

Vinnytsia, 21000, Ukraine

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Multiple Trauma; Acute Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; dmytrodmytriiev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 14, 2026
• Study Start: July 23, 2026
• Primary Completion: July 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

UA (1)