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Randomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.


- candidate number15140
- NTR NumberNTR4076
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jul-2013
- Secondary IDs2013/186 MEC UZ Brussel
- Public TitleRandomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.
- Scientific TitleRandomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.
- ACRONYMN/A
- hypothesisThe goal of this trial is to investigate the efficacy of the IMP during c-section with and without the use of Sufenta: As well as start of action, duration of action, the degree of motor and sensory block as well as the hight of the block itselfs will be investigated.
- Healt Condition(s) or Problem(s) studiedCaesarian section, Ampres, C-section, Chloroprocaine, Intrathecal, Bupivacaine, Sufentanil, Marcaine
- Inclusion criteriaAll healthy(ASA I-II) women with an uncomplicated singleton pregnancy between 18-40 y undergoing a planned caesarian.
Pregnancy > or equal to 37 weeks.
- Exclusion criteriaWomen who belong to ASA III-IV classification, BMI >35, length <150 cm, foetus with known fetal abnormality, pregnancy less than 37 weeks, known allergy for the used local anesthetics and (pre) eclampsia.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jul-2013
- planned closingdate31-dec-2013
- Target number of participants60
- InterventionsMeasurement of sensory and motor block, hemodynamic monitoring during procedure, feeling of nausea and vomitting, feeling of pain, relief of motor block.
- Primary outcomeEarlier releave of motor block (less then 90' after injection).
- Secondary outcomeN/A
- TimepointsEnd of c-section and final releave of motor block.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Veerle Mossevelde, van
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryEvaluation of the use of Chloroprocaine (and Sufentanil) during C-section and its effects on sensory and motor block.
- Main changes (audit trail)
- RECORD16-jul-2013 - 29-jul-2013


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