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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age ≥18 years

• Thoracic trauma from combat-related injuries

• VNRS ≥4 for acute thoracic pain

• Ability to provide informed consent

Locations
Other Locations
Ukraine
Communal enterprise Yuri Semenyuk Rivne Regional Clinical Hospital of Rivne Regional Council
RECRUITING
Rivne
Contact Information
Primary
Maksym Barsa, MD, PhD
maxbars@email.ua
+380952074098
Backup
Dmytro Dmytriiev, PhD, Dr.med.science, professor
+380674309449
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Cryoablation
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.
Active_comparator: Radiofrequency Ablation
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.
Related Therapeutic Areas
Sponsors
Leads: Lviv National Medical University
Collaborators: Vinnitsa National Medical University

This content was sourced from clinicaltrials.gov