Treatment with pregabalin (150-600 mg dose) results in a statistically significant improvement in endpoint mean pain score of ¡Ý 1,2 during 8 weeks follow-up relatively to treatment with placebo.
ID
Source
Brief title
Health condition
Patients suffering from chronic pain of neuropathic character after unilateral open inguinal hernia repair.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the mean 11-point numerical pain rating score in both treatment groups at baseline and follow-up.
Secondary outcome
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.
Background summary
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 (pfizer) reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.
Study objective
Treatment with pregabalin (150-600 mg dose) results in a statistically significant improvement in endpoint mean pain score of ¡Ý 1,2 during 8 weeks follow-up relatively to treatment with placebo.
Study design
N/A
Intervention
Placebo versus Pregabalin.
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL606 |
| NTR-old | NTR663 |
| CCMO | NL12428.078.06 |
| OMON | NL-OMON30188 |