|- candidate number||8526|
|- NTR Number||NTR2551|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2010|
|- Secondary IDs||80-82310-97-11039 ZonMW|
|- Public Title||Remifentanil patient gecontroleerde pijnstilling versus epidurale pijnstilling tijdens de bevalling.|
|- Scientific Title||Remifentanil patient controlled analgesia versus epidural analgesia during labour. A randomized multicenter trial.|
|- 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 women in labor.|
|- Healt Condition(s) or Problem(s) studied||Labour, Analgesia, Remifentanil , Epidural analgesia, PCA|
|- Inclusion criteria||1. Age >18 years;|
2. Labour between 32 and 42 weeks;
3. ASA physical status 1 or 2.
|- Exclusion criteria||1. Prior administration of opioid or regional analgesia;|
2. Drug allergy, hypersensitivity tot opiod or local analgesia substances;
3. Initial maternal SpO2 <98%;
4. Initial maternal temperature >38 degrees C;
5. Contra-indication for epidural analgesia.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-apr-2013|
|- Target number of participants||1136|
|- Interventions||Women will be randomized before actual labour starts. They will know which method of pain relief they are assigned. In the need for pain relief arrises they will be treated with remifentanil PCA or epidural analgesia.|
|- Primary outcome||This study will assess in women with a request for pain relief during labour the cost-effectiveness of RPCA as first choice treatment compared to EA.|
The economic analysis will be performed from a short-term healthcare perspective. Anticipating on equality in pain relief scores the economic analysis will be a cost minimization analysis.
For both strategies the cost of perinatal care for mother and child, starting at the onset of labor and ending ten days after delivery, will be registered and compared (without discounting).
The costs consist of costs of delivery/childbirth (course and mode of delivery), postnatal maternal care (hospitalization, outpatient visits), neonatal care (admission to NICU/neonatology ward, outpatient visits) and primary care (midwife, general practitioner, maternity care).
Volumes of hospital care are measured prospectively alongside the clinical study in all participating centers as part of the case record form. Health resource use outside the hospital will be recorded by questionnaires filled out by the patients. Costs of delivery/childbirth are estimated by a detailed cost price analysis in which units of resource use (time of hospital staff, materials, equipment) are valued using cost per unit estimates comprising "true economic" costs, i.e. including shares of fixed costs and hospital overheads. Costs per units are estimated for both a teaching and a non-teaching hospital. A secondary analysis based on reimbursement fees will be performed. Other resource use (hospital days, outpatient visits and primary care) will be valued using standard prices.
|- Secondary outcome||We will also look at the following outcomes:|
1. Pain relief scores;
2. Patient satisfaction;
3. Pain scores;
4. Maternal and neonatal side effects.
Pain scores and pain relief scores will be assessed using a visual analogue scale (VAS). For pain scores women will be asked to mark the level of pain experienced during contractions every hour, starting with a baseline VAS score before the institution of analgesia. Pain relief scores will be asked every hour and after delivery an overall satisfaction score (0-10) will be asked. Patient satisfaction will also be assesed by HADS and WDQ (Wijma Delivery Expectancy/Experience Questionnaire). Baseline non-invasive measurements will be made at regular intervals, including maternal blood pressure, heart rate, respiratory rate and pulse oximetry. Fetal heart rate and uterine activity will be measured continuously. Observations for known side effects will be made; respiratory depression, nausea/vomiting and itching. Side-effects will be managed by established protocols. At delivery neonatal outcome including Apgar scores and cord blood gas analysis and the Neurologic and Adaptive Capacity Score (NACS) and MAIN score will be recorded.
|- Timepoints||First inclusion january 2011, end of inclusion march 2013. Data analysis until september 2013.|
|- Trial web site||http://www.studies-obsgyn.nl|
|- CONTACT FOR PUBLIC QUERIES||Drs. L.M. Freeman|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.M. Middeldorp|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Problem:|
Epidural analgesia (EA) is considered to be the most effective method of pain relief during labor and is recommended as first method of pain relief by the Dutch Societies of Gynecologists and Anesthetists. In the Netherlands its uptake by pregnant women in labor of all ethnicities is still limited (10%), compared with other western countries (40-80%), mainly as a result of non-availability due to logistic problems.
To assess in women with a request for pain relief during labor the cost-effectiveness of remifentanil patient controlled analgesia (RPCA) as first choice compared to EA.
National multicenter randomized controlled trial (RCT), in 10 centers (university hospitals, teaching and non-teaching hospitals). Pregnant women with a request for pain relief during labor will be randomized before active labor has started to RPCA or EA.
Pregnant women will be offered to participate in the study. Only women who have been informed before active labor has started, will be eligible.
1. Remifentanil patient controlled analgesia;
2. Epidural analgesia.
2. Pain relief scores (pain-appreciation);
3. Patient satisfaction;
4. Pain scores (pain-intensity);
5. Maternal and neonatal side effects.
The initial analysis will be performed by intention to treat. We hypothesize that there is no difference in painrelief scores with the two sided test (alfa=0.05, power 1-beta=0.9). In this non-inferiority design in each group 102 women have to be treated to exclude a potential clinical relevant difference of 10% (10 point scale, estimated SD 2.2). After correction for cross-over and non-compliance 568 patients are required. When only 50 percent of all women need actually treatment 1136 women have to be randomized.
For both strategies the cost of perinatal care for mother and child of delivery and the next ten days after delivery will be registered and compared.
|- Main changes (audit trail)|
|- RECORD||4-okt-2010 - 25-apr-2011|