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)


Study to describe the processing of ropivacaine in the body when injected in the knee for pain treatment in total knee arthroplasty.


- candidate number26485
- NTR NumberNTR6306
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2017
- Secondary IDsNL60548.048.17 2017-000180-32
- Public TitleStudy to describe the processing of ropivacaine in the body when injected in the knee for pain treatment in total knee arthroplasty.
- Scientific TitlePharmacokinetic profile of ropivacaine after periarticular local infiltration analgesia for primary total knee arthoplast without the use of a tourniquet.
- ACRONYMLIakin II
- hypothesisnot applicable
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Ropivacaine
- Inclusion criteria- age 50-80 years
- ASA physical health classification I C II
- Body Mass Index (BMI) < 40
- Patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5%
- Scheduled for fast-track protocol TKA
- Hemoglobin (Hb) concentration 7.5 mMol/L
- Written informed consent
- Exclusion criteria- Placement of a surgical drain
- Contra-indications for spinal anesthesia
- Known hypersensitivity to amide-type local anesthetics
- Hepatic or renal insufficiency
- Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
- Any reason to perform surgery with the use of a tourniquet
- Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-mei-2017
- Target number of participants20
- Interventionsbloodsamples 12 times 5-10 ml
- Primary outcome- Mean total and unbound maximum serum concentration of ropivacaine (Cmax and Cumax)
- Mean time to total and unbound maximum serum concentration of ropivacaine (Tmax an Tumax)
- Secondary outcomenot applicable
- Timepointsbaseline, 20, 40, 60, 90, 120, 240 ,360, 480, 600, 720 and 1440 minutes after ropivacaine infiltration
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.M.K. Bakker
- CONTACT for SCIENTIFIC QUERIES S.M.K. Bakker
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Sint Maartenskliniek Nijmegen, dept. of Anesthesiology
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-jan-2017 - 19-mei-2017


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