Automated epidural pain relief for labor
Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
This study tests a new way of giving epidural pain relief during labor to see if it works better than the usual method for women who want help with pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04011150 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new method of administering epidural analgesia during labor, known as Variable Volume Automated Mandatory Bolus (VVAMB). The approach aims to enhance pain relief by allowing for a larger volume of local anesthetics to be delivered more effectively, potentially reducing the risk of motor blockade and the need for instrumental deliveries. The study will compare the effectiveness of VVAMB against a standard regimen in a group of 216 healthy women in early labor requesting epidural analgesia. The goal is to improve individualized pain management during labor.
Who should consider this trial
Good fit: Ideal candidates are healthy, first-time mothers at term who are in early labor and requesting epidural analgesia.
Not a fit: Patients with complications such as non-cephalic fetal presentation or uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain management for women in labor with fewer complications.
How similar studies have performed: Previous studies have shown that automated bolus techniques can improve pain relief, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Wan Ling Leong, FANZCA — KK Women's and Children's Hospital
- Study coordinator: Ban Leong Sng, FANZCA
- Email: sng.ban.leong@kkh.com.sg
- Phone: +6563941081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.