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
Bron
Verkorte titel
Aandoening
Patients suffering from chronic pain of neuropathic character after unilateral open inguinal hernia repair.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the mean 11-point numerical pain rating score in both treatment groups at baseline and follow-up.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Placebo versus Pregabalin.
Publiek
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
Wetenschappelijk
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL606 |
| NTR-old | NTR663 |
| CCMO | NL12428.078.06 |
| OMON | NL-OMON30188 |