Predictors of Treatment Failure Pain Among Patients With Mine-explosive Wounds

NCT ID: NCT05478655

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-24

Study Completion Date

2022-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Since in 87.2% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

retrospective analysis

A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation In all patients, the assessment of anesthetic risk was carried out according to the ASA scale.The basic tool for pain intensity research was a visual analog scale.The study of the neuropathic component of pain was carried out using the diagnostic questionnaire for the detection of neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. The presence of post-traumatic stress disorders was studied using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with the results of treatment was studied using the Chaban Quality of Life Scale.

visual analog scale

Intervention Type OTHER

VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.

prospective study

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients with gunshot wounds were evacuated to the stage of treatment - the National Military Medical Clinical Center "Main Military Clinical Hospital". The research was conducted using the same methods as during the retrospective analysis. The exception was the study period during treatment at the military medical clinical center: here it was 14 days.

visual analog scale

Intervention Type OTHER

VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

visual analog scale

VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4). ASA The Hospital Anxiety and Depression Scale Mississippi PTSD scale (military version) Chaban Quality of Life Scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* chronic pain, mine-explosive wounds

Exclusion Criteria

* absence of mine-explosive wounds
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bogomolets National Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vasyl' Horoshko

Chief researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ukraine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

№158 23/05/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Trust Game and Placebo Response
NCT02578212 COMPLETED NA
Chronic Pain Predictors in Major Trauma
NCT07237152 NOT_YET_RECRUITING