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Dural Puncture vs Standard Epidural for Labor Pain (DPE Trial)

N/A

Recruiting

Research Sponsored by Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after inclusion. from installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

Awards & highlights

DPE Trial Summary

This trial is testing whether a dural puncture epidural is better than a standard epidural in terms of how often a physician has to give extra pain relief during the first stage of labor.

Who is the study for?

This trial is for healthy pregnant women who speak French, are 18 or older, and want epidural pain relief during labor. They should be at term (37-42 weeks), with a single baby in head-down position, and not too far into labor (cervix dilated ≤ 5 cm). Women with pregnancy complications like high blood pressure or diabetes, allergies to study drugs, trouble speaking French, known fetal issues, or reasons they can't have an epidural aren't eligible.Check my eligibility

What is being tested?

The study compares two types of epidurals: dural puncture and standard. It's looking at how often doctors need to give extra doses of pain medicine during the first stage of labor. Pregnant women participating will randomly receive one type of epidural to see which requires fewer top-ups.See study design

What are the potential side effects?

Epidurals may cause side effects such as lower back discomfort where the needle goes in, headaches from leakage of spinal fluid (more common with dural puncture), slight drop in blood pressure, feeling sick or itchy skin.

DPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy pregnant woman seeking an epidural for labor pain.

DPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after inclusion. from installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after inclusion. from installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after inclusion. from installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Need for 1 physician epidural top-up

Secondary outcome measures

Ambulation

Ambulation criteria

Analgesia scores

+8 more

DPE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dural puncture epidural (group DPE)Experimental Treatment1 Intervention

The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique. In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA). In group DPE, a single dural puncture with confirmation of free-flow CSF will be performed. If there is no free-flow CSF return through the spinal needle, the epidural catheter will be threaded 4-5cm in the epidural space and the patient will still be assigned to the DPE group, as per "intent-to-treat" protocol.

Group II: Standard epidural (group EPL)Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dural puncture epidural

2021

N/A

~70

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor

70 Previous Clinical Trials

5,430 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this medical experiment?

"Indeed, the information found on clinicaltrials.gov displays that this medical trial is currently enrolling patients. It was first advertised to potential participants on January 19th 2021 and its status has been recently updated as of March 10th 2022."

Answered by AI

How many subjects are involved in this clinical trial?

"Affirmatively, according to clinicaltrials.gov there is an ongoing search for participants in this trial; it was first posted on January 19th 2021 and its last update occurred on March 10th 2022. The study requires 130 enrollees from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia

Philippe Richebe 2021. "Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04728048.