Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2007-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
placebo
placebo drug during 8 weeks
pregabalin
pregabalin
pregabalin 150-600mg/day during 8 weeks
Interventions
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pregabalin
pregabalin 150-600mg/day during 8 weeks
placebo
placebo drug during 8 weeks
Eligibility Criteria
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Inclusion Criteria
2. Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
3. Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
4. Duration pain ≥ 3 months
5. Medial or lateral inguinal hernia
6. Age ≥ 18 years
7. VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
8. Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
9. Informed consent (addendum V)
Exclusion Criteria
2. Age \< 18 years
3. Cognitive disfunction
4. Patient is unable to speak Dutch
5. Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Renal impairment
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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hasan eker
Prof. Dr. J.F. Lange
Principal Investigators
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J.F. Lange, professor
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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Other Identifiers
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pregabalin RCT
Identifier Type: -
Identifier Source: org_study_id
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