Perineuromal hydrodissection for acute postamputation pain? An observational study in a time of war.
Dmytro Dmytriiev, Winnie Liu, Maksym Barsa...
https://pubmed.ncbi.nlm.nih.gov/39971386Actively Recruiting
Led by Lviv National Medical University · Updated on 2026-02-02
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
L
Lviv National Medical University
Lead Sponsor
V
Vinnitsa National Medical University
Collaborating Sponsor
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
Comprehensive Multicenter Study on the Management of Acute Pain Following Thoracic Combat-Related Trauma in Ukraine
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Complete this quick 3-step screening to check your eligibility
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
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
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
Total: 1 location
1
Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council
Rivne, Ukraine
Actively Recruiting
M
Maksym Barsa, MD, PhD
D
Dmytro Dmytriiev, PhD, Dr.med.science, professor
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Dmytro Dmytriiev, Winnie Liu, Maksym Barsa...
https://pubmed.ncbi.nlm.nih.gov/39971386