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

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.

Study Overview

• Status: Completed
• Conditions: Gunshot Entry Wound
• Intervention / Treatment: Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic test: visual analogue scale (VAS); Diagnostic test: Douleur Neuropathique 4 questions (DN4)

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Behavioral: 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%).; Other Names: The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic test: visual analogue scale (VAS); pain intensity; Other Names: VAS; Diagnostic test: Douleur Neuropathique 4 questions (DN4); neuropathic pain component; Other Names: DN4
OTHER: 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.	Behavioral: 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%).; Other Names: The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic test: visual analogue scale (VAS); pain intensity; Other Names: VAS; Diagnostic test: Douleur Neuropathique 4 questions (DN4); neuropathic pain component; Other Names: DN4
OTHER: 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.	Behavioral: 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%).; Other Names: The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic test: visual analogue scale (VAS); pain intensity; Other Names: VAS; Diagnostic test: Douleur Neuropathique 4 questions (DN4); neuropathic pain component; Other Names: DN4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Vasyl' Horoshko
• Collaborators: Bogomolets National Medical University
• Investigators: Study Chair: Iurii Kuchyn, MD, National medical University named after O. O. Bogomolets, Kyiv, Ukraine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Post-traumatic Stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Wounds, Penetrating; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Wounds, Gunshot
• Other Study ID Numbers: BogomoletsNMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No