Comprehensive Multicenter Study on the Management of Acute Pain Following Thoracic Combat-Related Trauma in Ukraine
CMS-APT-UA
Management of Acute Pain After Thoracic Combat Trauma: A Multicenter Study in Ukraine
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
January 17, 2026
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 2, 2026
January 1, 2026
5 months
January 17, 2026
January 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4, 24, and 72 hours post-procedure.
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Cryoablation
ACTIVE COMPARATORParticipants 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.
Radiofrequency Ablation
ACTIVE COMPARATORParticipants 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Thoracic trauma from combat-related injuries
- VNRS ≥4 for acute thoracic pain
- Ability to provide informed consent
You may not qualify if:
- Severe coagulopathy
- Infection at intervention site
- Allergy to local anesthetics
- Inability to perform spirometry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council
Rivne, Ukraine
Related Publications (1)
Dmytriiev D, Liu W, Barsa M, Khomenko A, Strokan A, Pasquina PF, Cohen SP. Perineuromal hydrodissection for acute postamputation pain? An observational study in a time of war. Reg Anesth Pain Med. 2025 Feb 26:rapm-2024-106307. doi: 10.1136/rapm-2024-106307. Online ahead of print.
PMID: 39971386BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical director
Study Record Dates
First Submitted
January 17, 2026
First Posted
February 2, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share