No registrations found.
ID
Source
Brief title
Health condition
This study will assess in women with a request for pain relief during labor the costeffectiveness
of RPCA as first choice treatment compared to EA.
Epidurale anesthesie meest effectieve vorm van pijnbestrijding. Echter de tevredenheid van de patient tav epidurale anesthesie vergeleken met remifentanil, in dit geval laag risico zwangere, is niet bekend.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
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).
Intervention
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.
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;
2. Substances;
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3532 |
| NTR-old | NTR3687 |
| Other | METC LUMC : P10.240 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |