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Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder

Primary Purpose

Gunshot Entry Wound

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mississippi Scale for Combat-Related PTSD (M-PTSD)
visual analogue scale (VAS)
Douleur Neuropathique 4 questions (DN4)
Sponsored by
Vasyl' Horoshko
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gunshot Entry Wound focused on measuring Post-traumatic Stress Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • gunshot wounds
  • post-traumatic stress disorder
  • patients who need anesthesia

Exclusion Criteria:

  • the patient has no post-traumatic stress disorder
  • the patient has no gunshot wounds

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Group І received general anesthesia (n=53)

    Group II received regional anesthesia: peripheral block was performed (n=73)

    Group III received regional anesthesia with sedation (n=92)

    Arm Description

    The sedation with constant rate infusion of 1% propofol, 1-4mg/kg/h, guided by Bispectral analysis (60-70 - for regional anesthesia and 40-60 - for the general one). 0.005% fentanyl analgesia was injected, 3-10 mkg/kg or 0.05-0.2 mkg/kg/min during induction; and 2-10 mkg/kg/h for maintaining analgesia, by periodic bolus injection 25-100 mkg or by permanent infusion. The postoperative pain management of the I group patients was provided according to the local clinical protocol: paracetamol+/-non-steroid anti-inflammatory drugs +/-opioids. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.

    The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.

    The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.

    Outcomes

    Primary Outcome Measures

    Mississippi Scale for Combat-Related PTSD (M-PTSD)
    The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points. A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points and psychic disorders, which correspond to 112-95 points.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2020
    Last Updated
    December 28, 2020
    Sponsor
    Vasyl' Horoshko
    Collaborators
    Bogomolets National Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04689022
    Brief Title
    Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
    Official Title
    Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    December 30, 2019 (Actual)
    Study Completion Date
    October 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Vasyl' Horoshko
    Collaborators
    Bogomolets National Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The 82.1% treatment failure of post-traumatic stress disorder(PTSD), associated with gunshot wounds, is related to high incidence of chronic pain syndrome as well as resistance to the PTSD treatment. Defining treatment failure predictors among the PTSD patients with gunshot extremity wounds and the following therapy would improve treatment outcomes.
    Detailed Description
    It has been noted that the PTSD in military combatants results from their direct participation in military actions. The study revealed that if a military combatant was wounded during the action operation, his emotional and subjective feelings will 100% lead to the PTSD. Other scientists state about the PTSD remote treatment failure in 80% of the military combatants. The study evidences about 82.1% of the PTSD m-related wounds treatment failure, which was essential for the subsequent studies. Some authors state about treatment effectiveness of psychopharmacological drugs and psychotherapy, which is rather questionable. Traumas and somatic diseases in the PTSD patients are known to accumulate their negative effects. So, definition of the PTSD treatment failure predictors may improve treatment outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gunshot Entry Wound
    Keywords
    Post-traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A total of 218 patients completed the study. The Mississippi Scale for Combat-Related PTSD (M-PTSD) was used for assessment of the treatment outcome rate. The risk relation between treatment failure and factors was assessed by a univariate or multivariate logistic regression method, with the model accuracy measured by the AUC - Area under the ROC curve. The odds ratio (OR) was considered for the qualitative factor assessment.
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    218 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group І received general anesthesia (n=53)
    Arm Type
    Other
    Arm Description
    The sedation with constant rate infusion of 1% propofol, 1-4mg/kg/h, guided by Bispectral analysis (60-70 - for regional anesthesia and 40-60 - for the general one). 0.005% fentanyl analgesia was injected, 3-10 mkg/kg or 0.05-0.2 mkg/kg/min during induction; and 2-10 mkg/kg/h for maintaining analgesia, by periodic bolus injection 25-100 mkg or by permanent infusion. The postoperative pain management of the I group patients was provided according to the local clinical protocol: paracetamol+/-non-steroid anti-inflammatory drugs +/-opioids. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.
    Arm Title
    Group II received regional anesthesia: peripheral block was performed (n=73)
    Arm Type
    Other
    Arm Description
    The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.
    Arm Title
    Group III received regional anesthesia with sedation (n=92)
    Arm Type
    Other
    Arm Description
    The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mississippi Scale for Combat-Related PTSD (M-PTSD)
    Other Intervention Name(s)
    The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD)
    Intervention Description
    The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points, observed in 39 patients (17.9%). A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points, observed in 5 patients (2.3%) and psychic disorders, which correspond to 112-95 points, observed in 174 patients (79,8%).
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    visual analogue scale (VAS)
    Other Intervention Name(s)
    VAS
    Intervention Description
    pain intensity
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Douleur Neuropathique 4 questions (DN4)
    Other Intervention Name(s)
    DN4
    Intervention Description
    neuropathic pain component
    Primary Outcome Measure Information:
    Title
    Mississippi Scale for Combat-Related PTSD (M-PTSD)
    Description
    The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points. A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points and psychic disorders, which correspond to 112-95 points.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: gunshot wounds post-traumatic stress disorder patients who need anesthesia Exclusion Criteria: the patient has no post-traumatic stress disorder the patient has no gunshot wounds
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iurii Kuchyn, MD
    Organizational Affiliation
    National medical University named after O. O. Bogomolets, Kyiv, Ukraine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34717551
    Citation
    Kuchyn IL, Horoshko VR. Predictors of treatment failure among patients with gunshot wounds and post-traumatic stress disorder. BMC Anesthesiol. 2021 Oct 30;21(1):263. doi: 10.1186/s12871-021-01482-8.
    Results Reference
    derived

    Learn more about this trial

    Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder

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