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The effect of the combination of Midazolam with Ropivacaine on peripheral nerve blocks.


- candidate number11105
- NTR NumberNTR3304
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2012
- Secondary IDs2011/299 MEC UZ Brussel
- Public TitleThe effect of the combination of Midazolam with Ropivacaine on peripheral nerve blocks.
- Scientific TitleThe effect of the combination of Midazolam with Ropivacaine on peripheral nerve blocks.
- ACRONYMN/A
- hypothesisAddition of Midazolam to Ropivacaine should shorten the onset time of peripheral nerve block.
- Healt Condition(s) or Problem(s) studiedLimb surgery, Locoregional anesthesia
- Inclusion criteriaAll adult patients ASA class I and II scheduled for limb surgery.
- Exclusion criteria1. All patient allergic to the used substances;
2. All ASA class III and above and patients known with neuropathy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-feb-2012
- planned closingdate14-feb-2013
- Target number of participants100
- InterventionsPeripheral 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 50g midazolam with ropivacaine 7.5% perineurally.
Each group will be given 1mg midazolam IV as premedication.
- Primary outcomeShortening 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 outcomeEvaluation of quality and duration of blocks as well as the patient satisfaction.
- TimepointsImmediately after the procedure, 24 hrs and 6 weeks postoperatively.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Jigme Bhutia
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryThe 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)
- RECORD9-feb-2012 - 3-mrt-2012


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