search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Chronic pain after herniorraphy pregabalin versus placebo.


- candidate number2074
- NTR NumberNTR663
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2006
- Secondary IDsN/A 
- Public TitleChronic pain after herniorraphy pregabalin versus placebo.
- Scientific TitleChronic pain after herniorraphy pregabalin versus placebo.
- ACRONYMN/A
- hypothesisTreatment with pregabalin (150-600 mg dose) results in a statistically significant improvement in endpoint mean pain score of ¡İ 1,2 during 8 weeks follow-up relatively to treatment with placebo.
- Healt Condition(s) or Problem(s) studiedInguinal hernia
- Inclusion criteria1. 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 ¡İ 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 ¡İ 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate1-jun-2007
- Target number of participants122
- InterventionsPlacebo versus Pregabalin.
- Primary outcomeThe primary outcome is the mean 11-point numerical pain rating score in both treatment groups at baseline and follow-up.
- Secondary outcomeThe 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.F. Lange
- CONTACT for SCIENTIFIC QUERIESDrs. A.R. Wijsmuller
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- PublicationsN/A
- Brief summarySummary:
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.
- Main changes (audit trail)
- RECORD27-apr-2006 - 1-dec-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl