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Pharmacokinetic modelling of ropivacain in plastic surgery


- candidate number24083
- NTR NumberNTR5720
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mrt-2016
- Secondary IDsNL54819.015.15 
- Public TitlePharmacokinetic modelling of ropivacain in plastic surgery
- Scientific TitlePharmacokinetic modelling of ropivacain in plastic surgery
- ACRONYM
- hypothesisThe serumconcentration of ropivaca´ne 10mg/ml are low after local infiltration with the standard dosis.
- Healt Condition(s) or Problem(s) studiedPharmacokinetics
- Inclusion criteriahealthy patients older than 18 years who are undergoing breastreduction, abdominoplastic and endoscopic browlift in Maxima Medisch Centrum
- Exclusion criteriacontraindications for regional anesthesia, hypersensitivity for ropivacaine and any know heptic and/or renal failure.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 2-mei-2016
- planned closingdate29-jul-2016
- Target number of participants30
- InterventionsTake 6 bloodsamples after local infiltration with ropivacain.
- Primary outcomeParameters that influence the absorption of local infiltrated ropivacaine
- patientscharacteristics
- infiltrated area
- used dosage
- Secondary outcomeRelatioship between postoperative pain and serum concentration
- Timepointst=0, t=30 min, t=1 hour, t=2 hour, t=4 hour, t=8 hour
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Fechner
- CONTACT for SCIENTIFIC QUERIES M. Fechner
- Sponsor/Initiator Mßxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- Publications
- Brief summaryBackground: In plastic surgery of the MMC, the emphasis is on the use of local anesthetics to minimize the postoperative pain. The effective control of postoperative pain is not only very desirable for humanitarian reasons, it is more often that this provides significant physiological benefits.
With reducing post operative pain, is postoperative recovery faster, minimize clinical stay and return faster to work. About the absorption of ropivacaine and serum concentration is limited evidence. That is why we want to study the serum concentration of local infiltrated ropivaca´ne in venous blood.

Methods: For this study will thirty healthy patients older than 18 years who are undergoing breastreduction, abdominoplastic and endoscopic browlift in Maxima Medisch Centrum. Exclusion criteria included contraindications for regional anesthesia, hypersensitivity for ropivacaine and any know heptic and/or renal failure.
To determine the resorption of ropivaca´ne and serum concentration we will take 6 bloodsamples at t=0, t=30 min, t=1 hour, t=2 hour, t=4 hour, t=8 hour. A pharmacokinetic model for each procedure will be made by using a software package MW/Pharm ę (version 3.81).
- Main changes (audit trail)
- RECORD7-mrt-2016 - 2-mei-2016


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