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

NCT05478655 | Completed

• 1 other identifier: №158 23/05/2022
• Study Type: observational
• Target: 1,166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Chronic pain, mine-explosive wounds

Outcome Measures

Primary Outcomes (4)

• visual analog scale

  evaluation of the number of points

  12 months

• Didier Bouhassiraa DN4

  evaluation of the number of points

  12 months

• The Hospital Anxiety and Depression Scale

  evaluation of the number of points

  12 months

• Chaban Quality of Life Scale

  evaluation of the number of points

  12 months

Study Arms (2)

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.

Other: visual analog scale

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.

Other: visual analog scale

Interventions

visual analog scale 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.

Also known as: 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

prospective study; retrospective analysis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations. 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, within 12 months of the injury. 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.

You may qualify if:

• chronic pain, mine-explosive wounds

You may not qualify if:

• absence of mine-explosive wounds

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief researcher

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: February 24, 2022
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

UA (1)