Epidural vs. Dural Puncture Epidural in Labor Analgesia

NCT ID: NCT06849726

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-11-20

Brief Summary

Childbirth is both a physically and emotionally intense experience for mothers. Today, epidural analgesia is used during labor to improve maternal comfort and help ensure a safe, controlled delivery. Standard epidural analgesia is one of the most common methods used; however, it can sometimes cause issues like a one-sided block, insufficient pain relief, or motor block.

In recent years, the dural puncture epidural (DPE) technique has emerged as an alternative method to enhance the effectiveness of epidural analgesia. In the DPE method, a 27G spinal needle is used to puncture the dura before placing the epidural catheter. This allows cerebrospinal fluid to be seen, but no medication is injected into the intrathecal space. It is believed that DPE improves the spread of the epidural medication, reduces the time needed for a sacral block, and creates a more even block.

The primary aim of this study is to compare the effectiveness of standard epidural analgesia and DPE during labor, by measuring the rate at which patients achieve adequate pain relief (NRS < 4).

The secondary aims are to compare both methods regarding:

Changes in blood pressure and heart rate during labor, Changes in fetal heart rate, Occurrence of motor block, Need for additional pain relief, Side effects (such as low blood pressure, itching, nausea, vomiting, and fetal bradycardia), Risk of post-dural puncture headache, and Patient satisfaction with pain management and overall childbirth experience. The results of this study will help determine which epidural technique is more effective and safe for use during labor, thus contributing to improved clinical practice.

Detailed Description

The process of childbirth is an intensely demanding experience for mothers, both physically and psychologically. Contemporary epidural analgesia techniques, employed during labor, not only enhance maternal comfort but also contribute to the safe and controlled progression of delivery. Although standard epidural analgesia is one of the most frequently preferred methods for labor pain management and provides effective pain control, it is sometimes associated with disadvantages such as unilateral block, inadequate analgesia, or motor block.

In recent years, the dural puncture epidural (DPE) technique has emerged as an alternative method to improve the efficacy of epidural analgesia. In the DPE method, the dura is punctured using a 27G spinal needle prior to the placement of the epidural catheter, allowing the observation of cerebrospinal fluid without the administration of intrathecal medication. It is postulated that the DPE technique enhances the spread of the epidural solution, shortens the time required to achieve sacral block, and yields a more homogeneous block.

The primary objective of this study is to compare the adequacy and effectiveness of standard epidural analgesia versus dural puncture epidural analgesia during labor. Adequacy will be evaluated by the proportion of patients achieving the target pain score (NRS < 4).

The secondary objectives include comparing the two techniques with respect to hemodynamic changes during labor, alterations in fetal heart rate, development of motor block, need for additional analgesia, incidence of side effects (such as hypotension, pruritus, nausea, vomiting, fetal bradycardia), and the risk of post-dural puncture headache. Additionally, the study will assess the impact of each method on patient satisfaction with both postoperative analgesia management and the overall childbirth experience.

The findings of this study aim to elucidate which epidural analgesia technique is more effective and safe for use during labor, thereby contributing to clinical practice improvements.

Conditions

Labor Pain; Epidural Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Epidural Analgesia

In Group 1, nulliparous women in active labor will receive standard epidural analgesia. After standard monitoring and left lateral positioning, local anesthesia (40 mg of 2% lidocaine) is administered at the L3-L4 or L4-L5 interspace. Using an 18G Tuohy needle and the loss-of-resistance technique, the epidural space is identified, and the epidural catheter is inserted without prior use of a spinal needle. After confirming negative aspiration for CSF or blood, an initial dose of 15 mL of 0.125% bupivacaine with 30 μg fentanyl is administered through the catheter.

Group Type: ACTIVE_COMPARATOR

Standard Epidural Analgesia

Intervention Type: PROCEDURE

Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.

Dural Puncture Epidural (DPE) Analgesia

In Group 2, nulliparous women in active labor will receive the DPE technique. After identical patient preparation and local anesthetic infiltration at the L3-L4 or L4-L5 interspace, an 18G Tuohy needle is used via the loss-of-resistance method to locate the epidural space. Before inserting the epidural catheter, a 27G spinal needle is introduced through the Tuohy needle to puncture the dura, with the appearance of cerebrospinal fluid (CSF) confirming dural puncture. The spinal needle is then withdrawn without intrathecal drug administration, and the epidural catheter is inserted. Following negative aspiration, the same initial dose of 15 mL of 0.125% bupivacaine with 30 μg fentanyl is administered.

Group Type: ACTIVE_COMPARATOR

Dural Puncture Epidural Analgesia

Intervention Type: PROCEDURE

Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by the same standardized dose of bupivacaine with fentanyl.

Interventions

Standard Epidural Analgesia

Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.

Intervention Type: PROCEDURE

Dural Puncture Epidural Analgesia

Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by the same standardized dose of bupivacaine with fentanyl.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Nulliparous women
• Gestational age of ≥36 weeks with vertex presentation
• In active labor with cervical dilation ≤5 cm
• Electing for a pain-free vaginal delivery with one of the two epidural analgesia methods
• Provision of written informed consent

Exclusion Criteria

• Presence of pregnancy-related diseases (e.g., preeclampsia, gestational diabetes)
• Contraindications to neuraxial block
• Risk factors for cesarean delivery (e.g., uterine anomalies, previous surgeries, morbid obesity)
• Known fetal anomalies

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Burak Omur

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Lin W, Yang Y, Lin J, Chen J, Lin Q. Dural Puncture Epidural with 25-G Spinal Needles versus Conventional Epidural Technique in Conjunction with PIEB for Labor Analgesia: A Randomized Trial. J Pain Res. 2023 Nov 8;16:3797-3805. doi: 10.2147/JPR.S424082. eCollection 2023.

Reference Type: BACKGROUND

PMID: 38026464 (View on PubMed)

Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.

Reference Type: BACKGROUND

PMID: 32282386 (View on PubMed)

Wang J, Zhang L, Zheng L, Xiao P, Wang Y, Zhang L, Zhou M. A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. Ann Palliat Med. 2021 Jan;10(1):404-414. doi: 10.21037/apm-20-2281.

Reference Type: BACKGROUND

PMID: 33545772 (View on PubMed)

Other Identifiers

Epidural vs DP epidural

Identifier Type: -

Identifier Source: org_study_id