Comprehensive Multicenter Study on the Management of Acute Pain Following Thoracic Combat-Related Trauma in Ukraine

Conditions studied

Pain Management, Thoracic Trauma, Pulmonary Function, Quality of Life, Functional Outcome, Depression in Adults, Neuropathic Pain, Hypoesthesia

About this study

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…

Interventions

• Procedure: Cryoablation — Cryoablation 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
• Procedure: Radiofrequency ablation alone — Radiofrequency 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.

Primary outcomes

• Pain intensity (4, 24, and 72 hours post-procedure.)

Eligibility information

Study locations

• Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council, Rivne, Ukraine