Status:
COMPLETED
Chronic Pain Management After Herniorraphy
Lead Sponsor:
Erasmus Medical Center
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 d...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00772291
Start Date
May 1 2007
End Date
October 1 2010
Last Update
August 19 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE