Dural Puncture vs Standard Epidural for Labor Pain

(DPE Trial)

Overseen By Nadia Godin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must not be taking: Anticoagulation therapy

Disqualifiers: Gestational hypertension, Preeclampsia, Gestational diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 24 hours

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method for managing labor pain requires fewer doctor interventions: a dural puncture epidural or a standard epidural. The trial will compare these techniques to identify which is more effective during the first stage of labor. It suits healthy, full-term pregnant women with a single baby in the head-down position who speak French. As an unphased trial, participants contribute to valuable research that may enhance labor pain management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation therapy (medication that prevents blood clotting), you may not be eligible to participate.

What prior data suggests that these neuraxial analgesia techniques are safe for labor pain management?

Research shows that the dural puncture epidural (DPE) safely and effectively manages labor pain. Studies have found that the DPE provides faster and better pain relief compared to the standard epidural and usually has fewer side effects than methods like combined spinal epidurals. Although not yet used everywhere, evidence suggests patients tolerate the DPE well.

The standard epidural, a widely used technique, has been safely employed for many years. Both the DPE and the standard epidural involve placing a needle in the lower back to relieve pain, but the DPE includes an extra step of puncturing a membrane around the spinal cord. This extra step helps achieve quicker pain relief. Overall, research supports the safety of both techniques for managing labor pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of the dural puncture epidural (DPE) technique compared to the standard epidural procedure for managing labor pain. Unlike the standard epidural, which threads a catheter into the epidural space without puncturing the dura, the DPE involves a single dural puncture that can enhance the spread of anesthesia. This could potentially lead to faster and more effective pain relief during labor. By investigating these differences, researchers hope to find out if DPE offers better outcomes for mothers in labor.

What evidence suggests that this trial's treatments could be effective for labor pain?

Research has shown that the dural puncture epidural (DPE), which participants in this trial may receive, is a promising method for managing labor pain. Studies have found that DPE provides faster and more complete pain relief than the standard epidural, another treatment option in this trial. Reports indicate that DPE is 50% more effective in providing adequate pain relief. Additionally, DPE typically works more quickly and is less likely to cause muscle weakness compared to traditional epidurals, making it an appealing choice for efficient and effective pain management during labor. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your cervix is not dilated more than 5 centimeters.

I am a woman aged 18 or older.

The baby is in the head-down position for birth.

Exclusion Criteria

I don't have low platelet counts, spinal issues, or take blood thinners.

I have had conditions like high blood pressure or diabetes during pregnancy.

Difficulty understanding and speaking French

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Upon arrival at the birth unit

1 visit (in-person)

Treatment

Participants receive either dural puncture epidural or standard epidural analgesia during the first stage of labour

Up to 24 hours

Continuous monitoring during labour

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of analgesia and patient satisfaction

24 to 48 hours postpartum

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dural puncture epidural
• Standard epidural

Trial Overview

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.

How Is the Trial Designed?

Group I: Dural puncture epidural (group DPE) Experimental Treatment 1 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 Control 1 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 EPL, no dural puncture will be performed and the catheter will be threaded 4-5cm in the epidural space.

Dural puncture epidural is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Dural Puncture Epidural for:

• Labor analgesia

Approved in United States as Dural Puncture Epidural for:

• Labor analgesia
• Cesarean delivery anesthesia

Approved in Canada as Dural Puncture Epidural for:

• Labor analgesia

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Published Research Related to This Trial

The dural puncture epidural (DPE) technique provides faster onset of labor analgesia compared to the conventional epidural (EP) technique, as shown in a study of 116 nulliparous women.

Using DPE with programmed intermittent epidural bolus (PIEB) mode resulted in lower local anesthetic consumption and fewer patient-controlled bolus requests, without increasing side effects for mothers or newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Song, Y., Du, W., Zhou, S., et al.[2021]

The dural puncture epidural (DPE) technique provides a faster onset of pain relief and better bilateral sacral analgesia compared to traditional epidural methods, making it a promising option for labor analgesia.

DPE is associated with a lower incidence of asymmetric block and fewer maternal and fetal side effects, suggesting it has a favorable risk-benefit ratio for managing pain during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. Gunaydin, B., Erel, S.[2021]

In a study of 200 laboring patients, the Dural Puncture Epidural (DPE) technique provided significantly better pain relief at 10 minutes compared to Continuous Epidural Infusion (CEI), with 58.4% of patients achieving adequate analgesia versus 41.6% for CEI.

The DPE technique also resulted in a faster onset of adequate analgesia, with a median time of 8 minutes compared to 12 minutes for CEI, indicating that DPE may be a more effective method for managing labor pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. Wang, J., Zhang, L., Zheng, L., et al.[2021]

The Dural Puncture Epidural (DPE) technique provides faster pain relief for labor compared to the conventional Epidural (EP) technique, with a higher percentage of patients achieving satisfactory pain scores within 10 and 20 minutes after initiation.

Importantly, the DPE technique was found to have no associated adverse events for mothers or fetuses, indicating it is a safe option for labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dural puncture epidural versus conventional epidural analgesia for labor: a systematic review and meta-analysis of randomized controlled studies. Yin, H., Tong, X., Huang, H.[2022]

In a study involving 100 laboring women, the dural puncture epidural (DPE) technique combined with programmed intermittent epidural bolus (PIEB) showed that shorter PIEB intervals (35-40 minutes) provided effective analgesia for the majority of patients, with 89.5% and 84.2% receiving effective pain relief, respectively.

The optimal PIEB intervals for effective analgesia after DPE were found to be similar to those established for conventional epidural techniques, with estimated intervals of 52.5 minutes for 50% effectiveness and 37.0 minutes for 90% effectiveness, indicating consistency in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Assessment of the Optimal Time Interval Between Programmed Intermittent Epidural Boluses When Combined With the Dural Puncture Epidural Technique for Labor Analgesia. Yao, HQ., Huang, JY., Deng, JL., et al.[2023]

In a study of 140 women undergoing scheduled cesarean deliveries, the dural-puncture epidural (DPE) technique provided a significantly faster onset of surgical anesthesia compared to the standard epidural technique, with a median difference of 233 seconds.

The quality of anesthesia was also better with DPE, as only 15.7% of women in the DPE group experienced lower quality anesthesia compared to 36.3% in the standard epidural group, indicating DPE may be a more effective option for cesarean deliveries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. Sharawi, N., Williams, M., Athar, W., et al.[2023]

Combined spinal-epidural (CSE) without intrathecal opioids resulted in significantly lower consumption of epidural local anesthetic compared to both epidural (EPL) and dural puncture epidural (DPE), indicating greater efficiency in pain management during early labor.

CSE also provided faster onset of analgesia and higher rates of complete pain relief within the first hour, while showing no significant differences in side effects or maternal satisfaction compared to EPL and DPE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of epidural, dural puncture epidural, and combined spinal-epidural without intrathecal opioids for labor analgesia. Bakhet, WZ.[2022]

The dural puncture epidural (DPE) technique requires a lower dose of bupivacaine (29.30 mg) to achieve effective initial labor analgesia compared to the conventional epidural (EPL) technique, which requires 45.25 mg, indicating greater efficacy in pain management with less medication.

This study involved 100 women and used a biased-coin, sequential allocation method to determine the effective dose, demonstrating that the DPE technique provides faster and more effective analgesia with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Maeda, A., Villela-Franyutti, D., Lumbreras-Marquez, MI., et al.[2023]

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DURAL PUNCTURE EPIDURAL

Dural puncture epidural technique improves labor analgesia quality ... Labor Pain. Pathways. Described. First published. DPE study. Page 48. SMU - Internal Data.