|- candidate number||11105|
|- NTR Number||NTR3304|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-feb-2012|
|- Secondary IDs||2011/299 MEC UZ Brussel|
|- Public Title||The effect of the combination of Midazolam with Ropivacaine on peripheral nerve blocks.|
|- Scientific Title||The effect of the combination of Midazolam with Ropivacaine on peripheral nerve blocks.|
|- hypothesis||Addition of Midazolam to Ropivacaine should shorten the onset time of peripheral nerve block.|
|- Healt Condition(s) or Problem(s) studied||Limb surgery, Locoregional anesthesia|
|- Inclusion criteria||All adult patients ASA class I and II scheduled for limb surgery.|
|- Exclusion criteria||1. All patient allergic to the used substances;|
2. All ASA class III and above and patients known with neuropathy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||14-feb-2012|
|- planned closingdate||14-feb-2013|
|- Target number of participants||100|
|- Interventions||Peripheral nerve blocks on 100 patients scheduled for limb surgery. This procedure takes about 10 min.
Group A (50) will be administered 20ml of 7.5% ropivacaine.
Group B (50) will be administered 50µg midazolam with ropivacaine 7.5% perineurally.
Each group will be given 1mg midazolam IV as premedication.
|- Primary outcome||Shortening of the onset time of PNB by adding Midazolam to Ropivacaine:|
Each patient's sensory and motor nerve function will be evaluated every 3 min after administration of the drugs.
|- Secondary outcome||Evaluation of quality and duration of blocks as well as the patient satisfaction. |
|- Timepoints||Immediately after the procedure, 24 hrs and 6 weeks postoperatively.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Veerle Mossevelde, van|
|- CONTACT for SCIENTIFIC QUERIES|| Jigme Bhutia|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel|
|- Brief summary||The study is designed to evaluate the onset time of locoregional blocks with the use of Midazolam as an addjunctive to Ropivacaine.
|- Main changes (audit trail)|
|- RECORD||9-feb-2012 - 3-mrt-2012|