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

Vasyl' Horoshko

Status: Completed

Conditions: Gunshot Entry Wound

Treatments: Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

Study type: Interventional

Funder types: Other

Identifiers

NCT04689022

BogomoletsNMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 3 patient groups

Group І received general anesthesia (n=53)

Other group

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.

Treatment:

Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

Diagnostic Test: visual analogue scale (VAS)

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

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

Other group

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.

Treatment:

Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

Diagnostic Test: visual analogue scale (VAS)

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

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

Other group

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.

Treatment:

Diagnostic Test: Douleur Neuropathique 4 questions (DN4)

Diagnostic Test: visual analogue scale (VAS)

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