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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2020

Interventions

  • Drug: Gabapentin
    • Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
  • Drug: Metamizol
    • Standardized treatment
  • Drug: Tramadol
    • Standardized treatment

Arms, Groups and Cohorts

  • Experimental: Arm G1800
    • administration of gabapentin with a gradual increasing dose of up to 1800 mg / day
  • Active Comparator: G0
    • Standardized medical treatment of central neuropathic pain: metamizole, tramadol

Clinical Trial Outcome Measures

Primary Measures

  • Assessment the analgesic effect of gabapentin
    • Time Frame: in 3 months after initiation of the gabapentin treatment
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Masaryk University
  • Provider of Information About this Clinical Study
    • Sponsor

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