Comparing two methods of epidural pain relief in multiparous women during labor
Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Multiparous Women. A Randomized Controlled Trial
This study is testing whether a new way of giving epidural pain relief during labor can help women who have given birth before manage their pain better than the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Sex | Female |
| Sponsor | Holy Family Hospital, Nazareth, Israel Academic / other |
| Locations | 1 site (Nazareth) |
| Trial ID | NCT06580327 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of programmed intermittent bolus epidural analgesia (PIBEA) versus continuous epidural infusion (CEI) in managing breakthrough pain during labor in multiparous women. Participants will be randomly assigned to receive either PIBEA, which delivers medication at set intervals, or CEI, which provides a continuous dose. The study will assess outcomes such as the incidence of breakthrough pain, labor duration, and overall satisfaction with pain management. The goal is to determine if PIBEA can improve pain relief and reduce the need for additional interventions during labor.
Who should consider this trial
Good fit: Ideal candidates for this study are multiparous women in the latent phase of labor requesting epidural analgesia.
Not a fit: Patients with contraindications for epidural analgesia or those with certain fetal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and satisfaction for women in labor.
How similar studies have performed: Previous studies have shown promising results for intermittent bolus techniques in pain management, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. multiparous women 2. Term pregnancy 3. Singleton 4. Vertex presentation 5. Latent phase (cervical dilatation less than 6 cm) 6. Epidural analgesia request 7. Visual Analogue Scale score greater than 40 Exclusion Criteria: 1. Estimated fetal weight greater than 4.0 kg 2. Intra uterine fetal death 3. Drug sensitivity 5\. Anomalous fetus 6. Contraindication for epidural analgesia
Where this trial is running
Nazareth
- Holy Family Hospital — Nazareth, Israel (Recruiting)
Study contacts
- Study coordinator: Raed Salim, MD
- Email: r.salim@hfhosp.org
- Phone: 0544986960
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.