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

Introduction

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.

1. 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.

- 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.

All 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