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

Masaryk University

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Pain Due to Trauma Spinal Cord Injuries

Interventions

GabapentinDRUG

Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present

MetamizolDRUG

Standardized treatment

TramadolDRUG

Standardized treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and women, age 18 - 65 years 2. Signed written informed consent 3. Patients after complete/non-complete spinal lesion, after surgery 4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal) 5. Patient willing and able to comply with the study protocol 6. Male and females with a highly effective method of birth control plus an additional barrier method Exclusion Criteria: 1. Patients with spinal cord lesion ischemic etiology 2. Pregnant women, nursing or childbearing age with a positive pregnancy test input 3. Patients unable or unwilling to comply with the study protocol 4. Acute pancreatitis in 1 year from the start of the study 5. Chronic pancreatitis in the case history 6. Active or uncontrolled infectious diseases 7. Hypersensitivity to any component of the investigational product 8. Active autoimmune disease 9. Serious neurological disease with the incidence chronic neuropathic pain

Locations (1)

Fakultní nemocnice Brno

Brno, Czechia

Outcomes

Primary Outcomes

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

Time frame: in 3 months after initiation of the gabapentin treatment

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment

Data from ClinicalTrials.gov

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