Regional Anesthesia Burden and Clinical Outcomes in Polytrauma Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Early Functional Recovery at Day 7
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of polytrauma, defined as traumatic injuries involving two or more anatomical regions.
- •Injury Severity Score (ISS) ≥
- •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.
排除标准
- •Age younger than 18 years.
- •Isolated single-system injury without polytrauma. ISS <
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Early Functional Recovery at Day 7
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Dmytro Dmytriiev
PhD, Professor
Ukrainian Society of Regional Anesthesia and Pain Therapy