remifentanil, PCA, epidural, analgesia, labour
Conditions
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 ep
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Labour between 32 and 42 weeks; 3. ASA physical status 1 or 2.
Exclusion criteria
Exclusion criteria: 1. Prior administration of opioid or regional analgesia; 2. Drug allergy, hypersensitivity tot opiod or local analgesia substances; 3. Initial maternal SpO2 38 degrees C; 5. Contra-indication for epidural analgesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactL.M. Freeman
Postbus 9600
Outcome results
None listed