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.
ID
Bron
Verkorte titel
Aandoening
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.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Costeffectiveness of RPCA as first choice treatment compared to EA in low risk pregnant women.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age >18 years;
2. ASA physical status I or II;
3. Low risk pregnant women.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3532 |
| NTR-old | NTR3687 |
| Ander register | METC LUMC : P10.240 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |