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临床试验/NCT07380789
NCT07380789招募中不适用

Management of Acute Pain After Thoracic Combat Trauma: A Multicenter Study in Ukraine

Lviv National Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

This study is a multicenter clinical trial conducted in Vinnytsia, Rivne, and Lviv, Ukraine, focusing on the management of acute pain following thoracic injuries sustained during combat. The main purpose of the study is to evaluate and compare the effectiveness and safety of two minimally invasive procedures, cryoablation and radiofrequency ablation, in controlling severe chest pain and improving patients' recovery. Cryoablation involves applying extreme cold to specific intercostal nerves to reduce pain signals, while radiofrequency ablation uses controlled heat to achieve a similar effect. Both procedures target the nerves responsible for transmitting pain from the injured areas and are performed by experienced clinicians under careful monitoring to minimize risks. Adult patients who have experienced thoracic combat trauma and are experiencing moderate to severe pain may be eligible to participate in the study if they are able to provide informed consent and comply with the study procedures. Participants will be randomly assigned to receive either cryoablation or radiofrequency ablation. Pain intensity will be assessed before the procedure, and then again at four, twenty-four, and seventy-two hours afterward using a standardized verbal numeric rating scale. In addition to measuring changes in pain, the study will monitor opioid medication use to determine whether either procedure reduces the need for pain-relieving drugs. Mechanical pain sensitivity will be evaluated using Von Frey testing, and pulmonary function will be assessed using incentive spirometry to determine whether pain reduction improves the ability to breathe deeply and cough effectively. The impact of pain on daily activities, quality of life, and emotional well-being will also be measured using validated tools such as the LANS scale, the McGill Pain Questionnaire, and the PHQ-9 depression screening questionnaire. The study aims to provide important information on the relative benefits and risks of cryoablation and radiofrequency ablation for the treatment of acute thoracic pain, including changes in pain intensity, opioid consumption, respiratory function, and overall comfort. Potential risks associated with the procedures include temporary soreness, bruising, or rare complications, but all interventions are performed under strict safety protocols. Participation in this study may allow patients to experience better pain control, potentially reduced reliance on opioid medications, and faster recovery, while contributing valuable data that could improve pain management strategies for other patients in similar circumstances. Data collected during the study will be analyzed to compare the effectiveness of the two procedures and to identify factors that may influence outcomes, such as age, body mass index, the number of intercostal levels treated, and baseline pain scores. The study provides a structured, evidence-based approach to understanding acute pain management after thoracic combat injuries and aims to support clinicians in making informed decisions to improve patient care. For patients, families, and healthcare providers, this research offers an opportunity to participate in a carefully monitored clinical trial designed to enhance recovery and reduce suffering after serious chest trauma while advancing medical knowledge in the field of pain management.

详细描述

This study is a prospective, multicenter clinical investigation designed to compare cryoablation and radiofrequency ablation as interventional techniques for the management of acute pain following thoracic combat-related trauma in adult patients treated in Ukraine. Thoracic injuries sustained during combat are commonly associated with severe acute pain, which can negatively affect respiratory mechanics, impair coughing and mobilization, increase opioid requirements, and contribute to pulmonary complications and prolonged recovery. Effective and timely pain control is therefore a critical component of trauma care in this patient population.

Cryoablation and radiofrequency ablation are minimally invasive procedures that target peripheral nerves involved in pain transmission, most commonly intercostal nerves in the setting of thoracic trauma. Cryoablation induces a temporary and reversible disruption of nerve conduction through localized application of extreme cold, while radiofrequency ablation produces thermal modulation of nerve function using controlled radiofrequency energy. Both techniques aim to provide targeted analgesia while reducing reliance on systemic analgesics, particularly opioids. Although both approaches are used in clinical practice, comparative evidence regarding their effectiveness, functional impact, and opioid-sparing potential in patients with acute thoracic combat trauma remains limited.

The study will be conducted at multiple tertiary care centers in Vinnytsia, Rivne, and Lviv. Adult patients presenting with thoracic combat-related trauma and clinically significant acute pain will be screened for eligibility and enrolled after providing informed consent. Participants will be randomly assigned to receive either cryoablation or radiofrequency ablation as part of their acute pain management, in addition to standard trauma care according to institutional protocols. The selection of intercostal levels for treatment will be based on injury distribution and clinical assessment, following a standardized procedural approach to ensure consistency across centers.

Pain intensity will be assessed using the Verbal Numeric Rating Scale at baseline prior to intervention and at predefined time points after the procedure to evaluate early and short-term analgesic effects. Opioid consumption will be recorded before intervention and during follow-up and standardized to allow comparison between treatment groups. Because thoracic pain directly affects respiratory function, pulmonary performance will be evaluated using incentive spirometry before and after the intervention to assess changes in airflow and the ability to perform deep breathing and coughing maneuvers.

Mechanical pain sensitivity will be assessed using Von Frey testing to evaluate changes in nociceptive thresholds following treatment. Pain provoked by coughing, a clinically relevant indicator of functional pain control in thoracic trauma, will be measured using a visual analog scale. In addition, patient-reported outcome measures will be collected using validated instruments, including the LANS scale for neuropathic pain features, the McGill Pain Questionnaire for qualitative pain assessment, and the PHQ-9 to screen for depressive symptoms that may influence pain perception and recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Thoracic trauma from combat-related injuries
  • VNRS ≥4 for acute thoracic pain
  • Ability to provide informed consent

排除标准

  • Severe coagulopathy
  • Infection at intervention site
  • Allergy to local anesthetics
  • Inability to perform spirometry

研究组 & 干预措施

Cryoablation

Active Comparator

Participants assigned to this arm will receive intercostal nerve cryoablation as part of acute pain management following thoracic combat-related trauma. Cryoablation will be performed using a percutaneous, image-guided technique targeting intercostal nerves corresponding to the distribution of thoracic injury. Local cooling will be applied to produce a temporary and reversible interruption of nerve conduction with the aim of reducing pain transmission. The number of intercostal levels treated will be determined based on clinical assessment and injury pattern. Cryoablation will be administered in addition to standard trauma and supportive care according to institutional protocols.

干预措施: Cryoablation (Procedure)

Radiofrequency Ablation

Active Comparator

Participants assigned to this arm will receive intercostal nerve radiofrequency ablation as part of acute pain management following thoracic combat-related trauma. Radiofrequency ablation will be performed using a percutaneous, image-guided technique targeting intercostal nerves associated with the site of thoracic injury. Controlled radiofrequency energy will be applied to modulate nerve function and reduce pain transmission. The number of intercostal levels treated will be determined based on clinical assessment and injury pattern. Radiofrequency ablation will be administered in addition to standard trauma and supportive care according to institutional protocols.

干预措施: Radiofrequency ablation alone (Procedure)

结局指标

主要结局

Pain intensity

时间窗: 4, 24, and 72 hours post-procedure.

Pain intensity was assessed using the Verbal Numeric Rating Scale (VNRS), a validated 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity (worse outcome). Reduction in pain intensity was evaluated by comparing VNRS scores over time.

次要结局

  • Mechanical pain threshold(Before and 72 hours after)
  • Opioid consumption(before and 72 hours after ablation)
  • Forced Vital Capacity (FVC)(Before and 24 hours after)
  • Pain during coughing(Before and 24 hours after)
  • Evaluate quality of life and functional outcomes with Leeds Assessment of Neuropathic Symptoms and Signs LANS(6 month after)
  • Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ),(6 mounth)
  • Quality of life and functional outcomes were evaluated using the Patient Health Questionnaire-9 (PHQ-9)(6 mounth)

研究者

发起方
Lviv National Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maksym Barsa

Medical director

Yuri Semenyuk Rivne Regional Clinical Hospital

研究点 (1)

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