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临床试验/NCT07474506
NCT07474506尚未招募不适用

From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma - A Multicenter Comparative Cohort Study

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment.

研究概览

简要总结

To compare the effectiveness of continuous regional anaesthesia with standard pain management strategies for the treatment of acute pain in patients with war-related lower limb trauma.

详细描述

War-related lower limb trauma represents one of the most frequent and severe injury patterns in modern armed conflicts. Blast injuries, gunshot wounds, and complex soft-tissue damage often result in severe acute pain requiring repeated surgical procedures, prolonged hospitalization, and intensive rehabilitation.

Adequate pain management in this population is critical not only for immediate patient comfort but also for facilitating wound care, early mobilization, rehabilitation participation, and potentially reducing the risk of long-term pain syndromes.

Continuous regional anaesthesia (CRA), delivered through ultrasound-guided peripheral nerve catheters, allows prolonged targeted analgesia by continuous infusion of local anesthetics. Compared with systemic analgesia or single-shot regional blocks, CRA may provide superior and sustained pain control, reduce opioid exposure, and improve rehabilitation tolerance.

However, evidence regarding the effectiveness of continuous regional anaesthesia in war-related lower limb trauma remains limited, particularly in real-world trauma settings involving blast injuries and multi-stage reconstructive surgery.

This study aims to evaluate the effectiveness and safety of continuous regional anaesthesia compared with standard analgesic strategies in patients with war-related lower limb trauma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥18 years
  • war-related lower limb trauma
  • hospital admission requiring surgical treatment or wound management
  • documented pain assessment during hospitalization
  • availability of analgesic treatment data
  • informed consent where required

排除标准

  • age <18 years
  • isolated upper limb trauma
  • missing key pain outcome data
  • contraindication to regional anaesthesia prior to treatment
  • refusal to participate (for prospective component)

研究组 & 干预措施

Group B - Standard Analgesia (Control Group)

Patients receiving standard pain management without continuous regional anaesthesia, including:

systemic multimodal analgesia (opioids, NSAIDs, paracetamol, adjuvant medications) single-shot regional nerve block (if used) epidural analgesia where clinically indicated Analgesic strategy will follow standard clinical practice at each participating center.

Group A - Continuous Regional Anaesthesia (CRA)

atients receiving continuous peripheral nerve blockade using perineural catheters with continuous or intermittent infusion of local anesthetic.

Possible catheter locations include:

femoral nerve sciatic nerve popliteal sciatic nerve adductor canal fascia iliaca combined catheter techniques

结局指标

主要结局

Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment.

时间窗: Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.

Pain scores will be recorded: at rest during movement during wound care or dressing changes.

次要结局

  • Total opioid consumption during first 72 hours, expressed as morphine milligram equivalents (MME).(Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.)

研究者

发起方
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmytro Dmytriiev

Professor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

研究点 (1)

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