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

Trial Summary

What is the purpose of this trial?

The purpose of this prospective randomized controlled study is 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.

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 data supports the effectiveness of the dural puncture epidural treatment for labor pain?

Research shows that the dural puncture epidural (DPE) technique provides faster and more effective pain relief during labor compared to the standard epidural. It increases the percentage of patients experiencing satisfactory pain relief within 10 to 20 minutes without additional risks to the mother or baby. ^{1 2 3 4 5}

Is the Dural Puncture Epidural (DPE) technique safe for labor pain relief?

Research shows that the Dural Puncture Epidural (DPE) technique is generally safe for labor pain relief, with fewer side effects compared to other methods like the standard epidural and combined spinal-epidural. Studies found no increase in adverse events for mothers or babies when using DPE. ^{1 2 3 6 7}

How does the dural puncture epidural treatment differ from standard epidural for labor pain?

The dural puncture epidural (DPE) treatment is unique because it involves intentionally puncturing the dura with a spinal needle without injecting any medication, which leads to faster and more effective pain relief compared to the standard epidural. This technique also results in fewer side effects and a more balanced pain relief across the body. ^{1 2 4 6 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2023]

4. United States 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. [2021]

5. China pubmed.ncbi.nlm.nih.gov

A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. [2021]

7. India pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2023]