The hypothesis is that epidural analgesia will provide better painrelief during labor with less side-effects than remifentanil.
ID
Bron
Verkorte titel
Aandoening
Laborpain.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Quality of pain relief as determined by Visual Analogue Scale scores;<br>
2. Patient satisfaction;<br>
3. Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone.
Achtergrond van het onderzoek
Purpose of this study is to compare the analgesic efficacy and safety of remifentanil, administered as patient-controlled analgesia, with epidural analgesia.
Objective:
1. Quality of pain relief as determined by Visual Analogue Scale scores;
2. Patient satisfaction;
3. Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone.
Methods: 20 patients. One group will receive remifentanil patient controlled analgesia (bolus 40 microgram. lockout 2 min). The other group will receive epidural analgesia (ropivacaine/sufentanil). Analgesia will be admininsterd throughout the first stage of labor.
Baseline non-invasive measurements will be made at regular intervals. Pain and satisfaction scores will be assessed using a visual analogue scale (VAS). Fetal heart rate will be measured and scored as reactive or non reactive. Observations for known side effects will be made. At delivery Apgarscore, bloodgas analysis and NACS will be recorded.
Doel van het onderzoek
The hypothesis is that epidural analgesia will provide better painrelief during labor with less side-effects than remifentanil.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. 10 patients will receive remifentanil patient controlled analgesia;
2. 10 patients will receive epidural analgesia;
Medication will be started in active labor and will be continued untill full dilation of the cervix is achieved.
Publiek
M.R. Douma
Leiden 2300 RC
The Netherlands
0031 (0)6 14276591
maritdouma@hotmail.com
Wetenschappelijk
M.R. Douma
Leiden 2300 RC
The Netherlands
0031 (0)6 14276591
maritdouma@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ? 18 years;
2. Between 37 and 42 weeks of gestation;
3. Singleton pregnancy;
4. ASA physical status I or II.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. ASA physical status ? III;
2. Morbid obesity (BMI ? 40 kg/m2);
3. Substance abuse history;
4. High risk patients: including pre-eclampsia (diastolic pressure ? 100 mmHg, proteinuria), severe asthma (daily use of medication), insulin dependent diabetes mellitus, hepatic insufficiency or renal failure;
5. Premature labor;
6. Drug allergy; history of hypersensitivity to opioid or local anesthetic substances;
7. Cervical dilation >5cm.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1094 |
NTR-old | NTR1127 |
Ander register | : P07.120 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |