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Postoperative pain treatment following surgical intervention of the epifyse


- candidate number22041
- NTR NumberNTR5195
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2015
- Secondary IDsNL50837.015.14 
- Public TitlePostoperative pain treatment following surgical intervention of the epifyse
- Scientific TitleEpiphysiodesis for adolescents; what is the most effective postoperative pain treatment? An RCT
- ACRONYMPostoperative pain treatment follwing epiphysiodesis
- hypothesisThe hypothesis is that an epidural pain treatment for adolescents is more effective as postoperative pain treatment following an epiphysiodesis procedure compared to a post operative pain treatment with intraveneus PCA method.
- Healt Condition(s) or Problem(s) studiedPost operative, Pain
- Inclusion criteriaPatients should meet the following inclusion criteria: age between 12-16 year; “indication for epiphysiodesis”, namely boys for which the estimated final body length will be minimally 200 cm; for girls this will be 195 cm.
- Exclusion criteriaA patient should not meet the following exculison criteria: insufficient command of Dutch language; niet willing to participate; contraindications for surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-aug-2018
- Target number of participants70
- Interventionsa) epidural pain management: bupivacain 5mg/hour pump according to pain protocol for children of Máxima Medical Centre. The epidural pain protocol will be started at the beginning of the surgical procedure and will be 3 days in situ.
b) pain medication by intravenous PCA (pain pump): morfine 1mg/ml by pump with lockout time of 6 minutes and additional bolus of 1/2mg vaccording to pain protocol for children of Máxima Medical Centre.
- Primary outcomeNumber rating scale for pain during the first 5 days postsurgery
- Secondary outcomeNumber rating scale for pain at other follow-up measurements; co-medication use; adverse events; satisfaction score of the patient; hospital stay and KOOS
- TimepointsPrimary outcome: day 1-5 postsurgery

Secondary outcome: at 2 weeks, 6 weeks and 6 months
- Trial web site
- statusstopped
- CONTACT FOR PUBLIC QUERIESPhd Max Reijman
- CONTACT for SCIENTIFIC QUERIESPhd Max Reijman
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Cooperatie Orthopedie Groot Eindhoven
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-apr-2015 - 19-feb-2017


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