Comparing two epidural techniques for labor pain relief

A Randomized Clinical Study to Compare the Number of Physician Top-up Interventions During the First Stage of Labour Between Two Different Neuraxial Analgesia Techniques: the Dural Puncture Epidural and the Standard Epidural

This study is testing whether a new epidural technique can provide better pain relief during labor for healthy pregnant women compared to the standard method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Ciusss de L'Est de l'Île de Montréal (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT04728048 on ClinicalTrials.gov

What this trial studies

This prospective randomized controlled study aims to compare the effectiveness of dural puncture epidural (DPE) versus standard epidural (EPL) techniques in reducing the need for physician top-up interventions during the first stage of labor. The study will involve healthy pregnant women requesting epidural analgesia, focusing on those at term gestation. By utilizing a patient-controlled epidural analgesia (PCEA) protocol with ultra-low concentrations of local anesthetic, the researchers hypothesize that DPE will significantly improve labor analgesia quality compared to EPL. The primary outcome will be the incidence of parturients requiring physician top-ups.

Who should consider this trial

Good fit: Ideal candidates include healthy, French-speaking pregnant women aged 18 and older, at term gestation, requesting epidural analgesia.

Not a fit: Patients with pregnancy-related diseases or contraindications to neuraxial analgesia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management during labor, reducing the need for additional medical interventions.

How similar studies have performed: While the DPE technique has shown benefits in other studies, this specific comparison with EPL using ultra-low concentrations of anesthetic is novel.

Eligibility criteria

Inclusion Criteria:

1. Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
2. Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
3. Women 18 years old and older.
4. Administration of epidural analgesia between 7am and 4pm on weekdays.
5. Singleton and vertex presentation foetus.
6. Cervical dilatation ≤ 5 cm.
7. BMI ≤ 40.
8. French speaking

Exclusion Criteria:

1. Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
2. Contraindications to neuraxial analgesia: thrombocytopenia \< 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
3. Known important fetal anomalies.
4. Allergy to any of the medications used in the study.
5. Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
6. Difficulty understanding and speaking French.

Where this trial is running

Montreal, Quebec

• CIUSSS de l'Est de l'Île de Montréal — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Christian Loubert

Conditions: Obstetric Pain, Labor Pain, Anesthesia, Dural puncture epidural, Epidural, Low dose bupivacaine