|- candidate number||13715|
|- NTR Number||NTR3687|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2012|
|- Secondary IDs||P10.240 METC LUMC|
|- Public Title||Comparing patient satisfaction and costs between epidural and remifentanil during labour in low risk pregnant women.|
Vergelijking van tevredenheid en kosten tussen epidurale anesthesie met remifentanil bij laag risico zwangeren.
|- Scientific Title||Remifentanil patient controlled analgesia (RPCA)
versus epidural analgesia (EA) during labour.
A randomized multicenter trial.|
|- ACRONYM||Ravel 2 study/Ravel eerste lijn studie|
|- hypothesis||We hypothesize that RPCA is as effective in reducing pain relief scores as EA, with lower
costs and easier achievement of 24 hours availability of pain relief for low risk women in labor.|
|- Healt Condition(s) or Problem(s) studied||Labour, Remifentanil , Epidural analgesia|
|- Inclusion criteria||1. Age >18 years;|
2. ASA physical status I or II;
3. Low risk pregnant women.
|- Exclusion criteria||1. Drug allergy: History of hypersensitivity to opioid or local anesthetic;|
3. Labor before 32 weeks or after 42 weeks of gestation;
4. Initial maternal SpO2 of less than 95%;
5. Initial maternal temperature of 38C or higher;
6. Prior administration of regional of opioid analgesia (during this delivery).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-okt-2012|
|- planned closingdate||1-okt-2013|
|- Target number of participants||408|
|- Interventions||Epidural anesthesia versus remifentanil.
First line pregnant women will be included. They will know which form of treatment they will get once they request pain control. If they don't use pain control they will be part of the control group. During delivery pain- and satisfactionscores will be taken every hour. 2 hours postpartum another satisfactionscore will be taken regarding experienced pain.
Before randomisation and 6 weeks postpartum 2 questionnaires will be taken (Wijma $ HADS). Also, 10 days postpartum, a questionnaire will inventory the costs.
|- Primary outcome||Costeffectiveness of RPCA as first choice treatment compared to EA in low risk pregnant women.|
|- Secondary outcome||1. Pain appreciation;|
2. Patient satisfaction;
3. Pain scores;
4. Maternal and neonatal side effects.
|- Timepoints||The endpoint: Costs of both interventions, remifentanil PCA and epidural analgesia for pain relief during labor.|
Timepoint: Starting at the onset of labor and ending ten days after delivery.
The secondary endpoints: Maternal parameters:
1. Pain scores (timepoint: end of delivery);
2. Pain appreciation scores (timepoint 6 weeks after delivery);
3. Side effects (timepoint: end of delivery).
Endpoint neonatal outcome (timepoint discharge home).
|- Trial web site||www.studies-obsgyn.nl/ravel|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Sabine Logtenberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. B.W. Mol|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||In addition to Ravel (1) study, the Ravel 2 study started. To compare the differences in respect of paincontrol and costs, between the low risk pregnant women and women with a medical indication for pregnancy/delivery. |
|- Main changes (audit trail)|
|- RECORD||5-nov-2012 - 17-nov-2012|