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Differences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor


- candidate number4250
- NTR NumberNTR1498
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2008
- Secondary IDsP08.092 
- Public TitleDifferences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor
- Scientific TitleDifferences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor
- ACRONYMN/A
- hypothesis1. Epidural analgesia leads to a higher frequency of maternal fever as compared to patients receiving remifentanil PCA or no analgesia.
2. Maternal saturation scores are lower in parturients receiving remifentanil PCA compared to patients receiving epidural analgesia or no analgesia.
- Healt Condition(s) or Problem(s) studiedLabour pain, Analgesics, Remifentanil , Temperature, Saturation
- Inclusion criteria1. Age 18 years and older
2. Between 24-42 weeks of gestation
3. ASA I or II
- Exclusion criteria1. Prior administration of regional or opioid analgesia (during this delivery)
2. Morbid obesity (BMI > 40kg/m2)
3. Drug allergy: history of hypersensitivity to opioid or local anesthetic substances
4. Severe pre-eclampsia (proteinuria > 5 grams)
5. Use of antibiotics during delivery
6. Initial maternal SpO2 of less than 98%
7. Initial maternal temperature of 38 C or higher
8. Cervical dilation of > 7cm
9. Ruptured membranes for more than 24 hours at time of inclusion
10. Contraindication for epidural analgesia
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-okt-2010
- Target number of participants175
- InterventionsAll patients will enter the study in a control group (group with no analgesia). Patients requesting analgesia, will be randomized to one of two study groups:
1. remifentanil patient controlled analgesia
2. epidural analgesia
- Primary outcomeMain objective is to compare the side effects of remifentanil PCA with those of epidural analgesia. The evaluation will be based upon the following parameters:
1. maternal temperature
2. maternal saturation
- Secondary outcomeThe secondary objective:
To compare other known side effects, in particular;
- nausea
- pruritus
- sedation
- hypotension

Fetal oucome as determined by: - Apgar scores
- umbilical cord pH
- NACS
- requirement naloxone
- Timepoints- Maternal bloodpressure, heart rate, saturation and temperature will be measured at regular intervals.
- Fetal heart rate and uterine activity will be measured continuously.
- At delivery neonatal outcome including Apgar scores at 1 and 5 minutes, cord blood gas analysis and the Neurologic and Adaptive Capacity Score (NACS) will be recorded.
- Trial web siteN/A
- statusplanned
- 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)
- Publications
- Brief summaryIntroduction
Epidural analgesia is considered to be the best form of pain relief during labor. However its use has been associated with an increase of maternal temperature. This can lead to unnecessary administration of antibiotics during labor and observation and treatment for sepsis of neonates. A relatively new option for obstetric analgesia is remifentanil PCA. Possible adverse effects of remifentanil resemble those of other opioids and include hypotension and respiratory depression.

Hypothesis
Epidural analgesia leads to a higher incidence of maternal fever as compared to patients receiving remifentanil PCA or no analgesia.
Maternal saturation scores are lower in parturients receiving remifentanil PCA compared to patients receiving epidural analgesia or no analgesia.

Objective
The main objective of this study is to compare the side effects of remifentanil, administered intravenous patient-controlled, with those of epidural analgesia. The evaluation will be based upon the following outcome parameters:
Maternal temperature
Maternal saturation

Secondary Objective
To compare the incidences of other known side effects, in particular nausea, pruritus, sedation and hypotension.
Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone.

Methods
One hundred and seventy-five parturients will be recruited. Patients requesting analgesia will be randomized to receive either remifentanil PCA or epidural analgesia. Parturients receiving no analgesia will form the control group.
Maternal bloodpressure, heart rate, saturation and temperature will be measured at regular intervals. Painscores will be assessed using a visual analogue scale.
Fetal heart rate and uterine activity will be measured continuously. At delivery neonatal outcome including Apgar scores at 1 and 5 minutes, cord blood gas analysis and the Neurologic and Adaptive Capacity Score (NACS) will be recorded.

Poweranalysis
A total population of 175 patients is needed for this trial.
- Main changes (audit trail)
- RECORD20-okt-2008 - 28-okt-2008


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