Chronic Pain Management After Herniorraphy
Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: pregabalin (Drug); placebo (Drug)
Phase: Phase 3
Sponsored by: Erasmus Medical Center
Official(s) and/or principal investigator(s):
J.F. Lange, professor, Principal Investigator, Affiliation: Erasmus Medical Center
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.
Official title: Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: pain
Secondary outcome: quantitative sensory testing (QST) accuracy in testing the inguinal region
Minimum age: 18 Years.
Maximum age: N/A.
1. History of unilateral inguinal herniotomy
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)
1. Participation in another trial
2. Age < 18 years
3. Cognitive disfunction
4. Patient is unable to speak Dutch
5. Hereditary problems of galactose intolerance, Lapp lactase deficiency or
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Renal impairment
Locations and Contacts
Erasmus Medical Center, Rotterdam 3015CE, Netherlands
Starting date: May 2007
Last updated: August 18, 2011