Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07380789

Management of Acute Pain After Thoracic Combat Trauma Using Cryoablation or Radiofrequency Ablation A Multicenter Study in Ukraine

Led by Lviv National Medical University · Updated on 2026-02-02

50

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

L

Lviv National Medical University

Lead Sponsor

V

Vinnitsa National Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two minimally invasive procedures, cryoablation and radiofrequency ablation, for managing acute pain following thoracic injuries sustained during combat. This multicenter clinical trial in Ukraine aims to compare the effectiveness and safety of these treatments in reducing severe chest pain and improving recovery. Both methods target intercostal nerves responsible for pain transmission, with the goal of reducing pain intensity, opioid use, and improving respiratory function and quality of life. Participants will be randomly assigned to receive either cryoablation or radiofrequency ablation, performed using percutaneous, image-guided techniques. Cryoablation applies extreme cold to temporarily interrupt nerve conduction, while radiofrequency ablation uses controlled heat to modulate nerve function. The number of intercostal levels treated depends on the injury pattern, and both procedures are delivered alongside standard trauma care. Assessments occur before and after the procedures to measure pain relief and functional improvements. During the study, participants will have pain intensity measured at 4, 24, and 72 hours post-procedure using a verbal numeric rating scale. Researchers will also monitor opioid medication use, mechanical pain sensitivity via Von Frey testing, and pulmonary function through incentive spirometry. Quality of life and emotional well-being will be assessed with validated tools including the LANS scale, McGill Pain Questionnaire, and PHQ-9 depression screening. Safety monitoring will focus on immediate and early complications. The study spans acute treatment and follow-up periods to support improved pain management decisions in this patient group.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Thoracic trauma from combat-related injuries
  • Moderate to severe acute thoracic pain (VNRS 4 or higher)
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Severe blood clotting problems (coagulopathy)
  • Infection at the site planned for intervention
  • Allergy to local anesthetics
  • Inability to perform breathing tests such as spirometry

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and informed consent

Treatment

Duration - Single procedure with follow-up assessments up to 72 hours

Participants receive either cryoablation or radiofrequency ablation using a percutaneous, image-guided technique targeting intercostal nerves involved in thoracic combat-related trauma. These procedures aim to reduce acute pain by temporarily modulating nerve function and are given in addition to standard trauma and supportive care.

1 procedure visit and 3 follow-up visits at 4, 24, and 72 hours post-procedure

Follow-up

Duration - 6 months

Participants are monitored for quality of life, functional outcomes, and long-term effects on neuropathic pain and depression using validated questionnaires and assessments.

1 visit at 6 months for outcome assessments

Trial Site Locations

Total: 1 location

1

Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council

Rivne, Ukraine

Actively Recruiting

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Research Team

M

Maksym Barsa, MD, PhD

D

Dmytro Dmytriiev, PhD, Dr.med.science, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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