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.
Age ≥18 years
Thoracic trauma from combat-related injuries
VNRS ≥4 for acute thoracic pain
Ability to provide informed consent
Severe coagulopathy
Infection at intervention site
Allergy to local anesthetics
Inability to perform spirometry
Parallel
Cryoablation
Procedure/SurgeryCryoablation and radiofrequency ablation are minimally invasive interventional pain management techniques used in this study to target intercostal nerves involved in pain transmission following thoracic combat-related trauma. Cryoablation achieves analgesia through the localized application of extreme cold, producing a temporary and reversible interruption of nerve conduction while preserving nerve structure. In contrast, radiofrequency ablation uses controlled radiofrequency-generated thermal energy to modulate nerve function and reduce pain transmission. Both interventions are performed percutaneously under image guidance to ensure accurate targeting of the affected intercostal nerves, with the number of treated levels determined by injury pattern and clinical assessment. Each intervention is administered in addition to standard trauma and supportive care, with the aim of reducing acute pain intensity, limiting opioid requirements, and improving functional outcomes such as respirator
Radiofrequency ablation alone
Procedure/SurgeryRadiofrequency ablation is a minimally invasive interventional technique that uses controlled radiofrequency-generated thermal energy to modulate peripheral nerve function and reduce pain transmission. In this study, radiofrequency ablation is applied to intercostal nerves associated with thoracic combat-related trauma using a percutaneous, image-guided approach. Thermal energy is delivered in a controlled manner to achieve nerve modulation while limiting damage to surrounding tissues. This intervention is intended to provide effective acute pain relief, reduce opioid requirements, and improve functional outcomes such as respiratory mechanics in patients with thoracic injuries.
Pain intensity
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.
Mechanical pain threshold
Assess mechanical pain threshold changes using Von Frey test
Opioid consumption
Compare opioid consumption
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) Pulmonary function was assessed using incentive spirometry by measuring Forced Vital Capacity (FVC), expressed in liters (L). FVC was recorded pre-ablation and post-ablation. Higher values indicate better pulmonary function.
Pain during coughing
Pain during coughing was assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain." Higher scores indicate greater pain intensity (worse outcome).
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Lviv National Medical University
Lead sponsor
Yuri Semenyuk Rivne Regional Clinical Hospital
Sponsor institution
Vinnitsa National Medical University
Collaborator
