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

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.

Demographic and clinical variables, including age, body mass index, baseline pain severity, and the number of intercostal levels treated, will be collected to support exploratory and adjusted analyses. Data will be entered into a standardized electronic case report form to ensure data quality and consistency across sites. Statistical analyses will include assessment of within-group changes over time and between-group comparisons of pain reduction, opioid use, respiratory function, and patient-reported outcomes. Multivariable analyses may be performed to identify factors associated with treatment response and clinically meaningful pain reduction.

Safety will be monitored throughout the study period. All procedures will be performed by clinicians experienced in interventional pain management techniques, following established institutional and procedural safety standards. Adverse events related to the interventions will be documented and reviewed. Given the acute nature of the intervention and follow-up period, safety assessments will focus on immediate and early procedural complications.

This study aims to generate clinically relevant evidence regarding the comparative effectiveness and safety of cryoablation and radiofrequency ablation for acute pain management following thoracic combat-related trauma. The results are expected to inform clinical decision-making, support optimization of pain management strategies, reduce opioid exposure, and improve functional recovery in this high-risk patient population.