Chronic Pain Management After Herniorraphy
- Registration Number
- NCT00772291
- Lead Sponsor
- Erasmus Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - pregabalin pregabalin -
- Primary Outcome Measures
Name Time Method pain 8 weeks
- Secondary Outcome Measures
Name Time Method quantitative sensory testing (QST) accuracy in testing the inguinal region 8 weeks
Trial Locations
- Locations (1)
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands