Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

Launched by KK WOMEN'S AND CHILDREN'S HOSPITAL · Jul 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to provide pain relief during labor for women who are having their first baby. The researchers are testing a method called Variable Volume Automated Mandatory Boluses (VVAMB), which aims to give a larger amount of pain medication quickly. This could help spread the medicine better and reduce the chance of unwanted side effects that can occur with traditional methods, making labor a smoother experience.

To participate in this trial, women must be healthy, at least 36 weeks pregnant, and in early labor with a single baby. They also need to be able to receive a specific type of epidural pain relief. However, women with certain medical conditions or complications, such as specific types of high blood pressure or certain fetal positions, will not be eligible. If someone joins the study, they can expect to receive personalized pain relief during labor and contribute to important research that could improve care for future parents.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
• • Singleton fetus;
• • In early labor stage (cervical dilation ≤5cm);
• • Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.
• Exclusion Criteria:
• • Non-cephalic fetal presentation;
• • Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
• • Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
• • Dural puncture/ suspected dural puncture at initiation of CSEA.