The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma

Study Overview
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Brief Summary
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Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

Official Title
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The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma

Conditions
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Chronic Pain Due to Trauma, Spinal Cord Injuries

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Metamizol
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 18 - 65 years Signed written informed consent Patients after complete/non-complete spinal lesion, after surgery Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal) Patient willing and able to comply with the study protocol Male and females with a highly effective method of birth control plus an additional barrier method Exclusion Criteria: Patients with spinal cord lesion ischemic etiology Pregnant women, nursing or childbearing age with a positive pregnancy test input Patients unable or unwilling to comply with the study protocol Acute pancreatitis in 1 year from the start of the study Chronic pancreatitis in the case history Active or uncontrolled infectious diseases Hypersensitivity to any component of the investigational product Active autoimmune disease Serious neurological disease with the incidence chronic neuropathic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm G1800<br>administration of gabapentin with a gradual increasing dose of up to 1800 mg / day | Drug: Gabapentin<br>* Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present<br>* Other names: Gabapentinum;|
| Active Comparator: G0<br>Standardized medical treatment of central neuropathic pain: metamizole, tramadol | Drug: Metamizol<br>* Standardized treatment<br>Drug: Tramadol<br>* Standardized treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment the analgesic effect of gabapentin | The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment in 3 months after initiation of the gabapentin treatment | in 3 months after initiation of the gabapentin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of the incidence of chronic neuropathic pain | The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment | in 6., 9. and 12. months after initiation of the gabapentin treatment | 
| The number of painful episodes | The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment) | in 3., 6., 9. and 12. months after initiation of the gabapentin treatment | 
| The decrease of the consumption of rescue medication | The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment | in 3., 6., 9. and 12. months after initiation of the gabapentin treatment | 
| Absolute and percentage change in average pain | Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months | in 3., 6., 9. and 12. months | 
| Quality of life | Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R | in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment |