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)


A randomized controlled trial for Local Tumescent anesthesia with phlebectomy according to the Muller method.


- candidate number17519
- NTR NumberNTR4534
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2014
- Secondary IDs12-T-77 METC
- Public TitleA randomized controlled trial for Local Tumescent anesthesia with phlebectomy according to the Muller method.
- Scientific TitleA randomized controlled trial for Local Tumescent anesthesia with phlebectomy according to the Muller method.
- ACRONYMLTAF
- hypothesisThe aim of this randomised controlled trial is to compare if adding sodium bicarbonate 1.4% to lidocain chloorhydrate 1% and epinifrine 0.9% results in significant less per-and postoperative pain in comparison with the routine LTA epinifrine 0.9% and lidocain chloorhydrate 1% in ambulant phlebectomy according to the Muller Method.
- Healt Condition(s) or Problem(s) studiedTumescent anaesthesia, Varicose veins, Sodium bicarbonate
- Inclusion criteriaOlder than 18 years Indication for Muller Phlebectomy according to the CEAP classification
- Exclusion criteriaallergy to anesthesia acute diseases chronic kidney- or liver failure analgetics treatment treatment with monoamine oxidase inhibitors or tricyclic antidepressants psychiatric illness according to the DSM-IV classification criteria alcohol abuses
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate23-jun-2014
- Target number of participants110
- InterventionsIntevention: lidoca´ne chloorhydrate 1% with epinephrine in natriumbicarbonate1.4% Control: standard LTA (lidoca´ne chloorhydrate 1% with epinephrine in normal saline 0.9%
- Primary outcomePer- and postoperative pain
- Secondary outcomecomplications time to full recovery/functionality cost reduction.
- TimepointsPer-operative 2 hours postoperative 1 day postoperative 2 days postoperative 7 days postoperative 14 days postoperative
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. A.G. Krasznai
- CONTACT for SCIENTIFIC QUERIESDrs. T.A. Sigterman
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsNone
- Brief summaryThe aim of this randomised controlled trial is to compare if adding sodium bicarbonate 1.4% to lidocain chloorhydrate 1% and epinifrine 0.9% results in significant less per-and postoperative pain in comparison with the routine LTA epinifrine 0.9% and lidocain chloorhydrate 1% in ambulant phlebectomy according to the Muller Method. Secondary outcomes are complications, time to full recovery/functionality and cost reduction.
- Main changes (audit trail)
- RECORD17-apr-2014 - 21-mei-2014


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