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

NCT04689022 | Completed DMC

• 1 other identifier: BogomoletsNMU
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gunshot Entry Wound

Keywords

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group І received general anesthesia (n=53)

OTHER

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); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

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

OTHER

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); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

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

OTHER

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); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

Interventions

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

Also known as: The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD (M-PTSD)

Group II received regional anesthesia: peripheral block was performed (n=73); Group III received regional anesthesia with sedation (n=92); Group І received general anesthesia (n=53)

visual analogue scale (VAS) DIAGNOSTIC_TEST

pain intensity

Also known as: VAS

Group II received regional anesthesia: peripheral block was performed (n=73); Group III received regional anesthesia with sedation (n=92); Group І received general anesthesia (n=53)

Douleur Neuropathique 4 questions (DN4) DIAGNOSTIC_TEST

neuropathic pain component

Also known as: DN4

Group II received regional anesthesia: peripheral block was performed (n=73); Group III received regional anesthesia with sedation (n=92); Group І received general anesthesia (n=53)

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vasyl' Horoshko: lead
• Bogomolets National Medical University: collaborator

Related Publications (1)

• 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.

  PMID: 34717551 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Iurii Kuchyn, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 30, 2020
• Study Start: April 1, 2014
• Primary Completion: December 30, 2019
• Study Completion: October 1, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share