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A comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor.


- candidate number2872
- NTR NumberNTR1127
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2007
- Secondary IDsP07.120 
- Public TitleA comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor.
- Scientific TitleA comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor.
- ACRONYMN/A
- hypothesisThe hypothesis is that epidural analgesia will provide better painrelief during labor with less side-effects than remifentanil.
- Healt Condition(s) or Problem(s) studiedLabour pain
- Inclusion criteria1. Age ? 18 years;
2. Between 37 and 42 weeks of gestation;
3. Singleton pregnancy;
4. ASA physical status I or II.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-nov-2007
- planned closingdate1-mrt-2008
- Target number of participants20
- Interventions1. 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.
- Primary outcome1. 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.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. M.R. Douma
- CONTACT for SCIENTIFIC QUERIESDr. R. Stienstra
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryPurpose 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.
- Main changes (audit trail)
- RECORD17-nov-2007 - 4-jun-2008


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