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

NCT ID: NCT04689022

Last Updated: 2020-12-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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Gunshot Entry Wound

Keywords

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group І received general anesthesia (n=53)

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.

Group Type OTHER

Mississippi Scale for Combat-Related PTSD (M-PTSD)

Intervention Type BEHAVIORAL

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%).

visual analogue scale (VAS)

Intervention Type DIAGNOSTIC_TEST

pain intensity

Douleur Neuropathique 4 questions (DN4)

Intervention Type DIAGNOSTIC_TEST

neuropathic pain component

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

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.

Group Type OTHER

Mississippi Scale for Combat-Related PTSD (M-PTSD)

Intervention Type BEHAVIORAL

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%).

visual analogue scale (VAS)

Intervention Type DIAGNOSTIC_TEST

pain intensity

Douleur Neuropathique 4 questions (DN4)

Intervention Type DIAGNOSTIC_TEST

neuropathic pain component

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

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.

Group Type OTHER

Mississippi Scale for Combat-Related PTSD (M-PTSD)

Intervention Type BEHAVIORAL

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%).

visual analogue scale (VAS)

Intervention Type DIAGNOSTIC_TEST

pain intensity

Douleur Neuropathique 4 questions (DN4)

Intervention Type DIAGNOSTIC_TEST

neuropathic pain component

Interventions

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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, 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 BEHAVIORAL

visual analogue scale (VAS)

pain intensity

Intervention Type DIAGNOSTIC_TEST

Douleur Neuropathique 4 questions (DN4)

neuropathic pain component

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD) VAS DN4

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bogomolets National Medical University

OTHER

Sponsor Role collaborator

Vasyl' Horoshko

OTHER

Sponsor Role lead

Responsible Party

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Vasyl' Horoshko

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Iurii Kuchyn, MD

Role: STUDY_CHAIR

National medical University named after O. O. Bogomolets, Kyiv, Ukraine

References

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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.

Reference Type DERIVED
PMID: 34717551 (View on PubMed)

Other Identifiers

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BogomoletsNMU

Identifier Type: -

Identifier Source: org_study_id