Patients suffering from chronic pain of neuropathic character after unilateral open inguinal hernia repair.
Conditions
Interventions
Placebo versus Pregabalin.
Sponsors
Pfizer bv
Eligibility
Inclusion criteria
Inclusion criteria: 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 ¡Ý 3 months; 5. Gender: Male; 6. Medial or lateral inguinal hernia; 7. Age >= 18 years; 8. Description III or IIIV of pain interfering with daily activity; 9. VAS score ¡Ý 40 mm on Vas scale on which they indicate ¡®how unpleasant or disturbing the worst pain was that they had today¡;¯ 10. Informed consent (addendum V).
Exclusion criteria
Exclusion criteria: 1. Participation in another trial; 2. Bilateral hernia; 3. Recurrent hernia; 4. Age < 18 years; 5. Cognitive disfunction; 6. Patient is unable to speak Dutch; 7. Description III or IV of pain interfering with daily activity; 8. Patient classified as American Society of Anaesthesiologist Class 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the mean 11-point numerical pain rating score in both treatment groups at baseline and follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are the mean light-touch and thermal QST thresholds between the painful inguinal area and the normal contra-lateral side in patients from both treatment groups at baseline and follow-up. | — |
Contacts
Public ContactJ.F. Lange
Erasmus Medical Center, Department of Surgery, P.O.Box 2040
Outcome results
None listed