Chronic Pain Management After Herniorraphy
pregabalin
1 other identifier
interventional
140
1 country
1
Brief Summary
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-pain
Started May 2007
Longer than P75 for phase_3 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedAugust 19, 2011
August 1, 2011
3.3 years
October 13, 2008
August 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain
8 weeks
Secondary Outcomes (1)
quantitative sensory testing (QST) accuracy in testing the inguinal region
8 weeks
Study Arms (2)
placebo
PLACEBO COMPARATORpregabalin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- History of unilateral inguinal herniotomy
- Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
- Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
- Duration pain ≥ 3 months
- Medial or lateral inguinal hernia
- Age ≥ 18 years
- VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
- Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
- Informed consent (addendum V)
You may not qualify if:
- Participation in another trial
- Age \< 18 years
- Cognitive disfunction
- Patient is unable to speak Dutch
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
- Patient classified as American Society of Anaesthesiologist Class 4
- Renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medical Center
Rotterdam, 3015CE, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J.F. Lange, professor
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. J.F. Lange
Study Record Dates
First Submitted
October 13, 2008
First Posted
October 15, 2008
Study Start
May 1, 2007
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
August 19, 2011
Record last verified: 2011-08