Clinical trial NCT06849726: Epidural vs. Dural Puncture Epidural in Labor Analgesia
Official title: Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Epidural Analgesia
Keywords: Labor Analgesia
Epidural Analgesia
Dural Puncture Epidural
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adequate Analgesia Achievement (NRS < 4)
timeFrame: Assessed at 5, 10, and 15 minutes after each epidural dose administration.
Secondary outcomes:
measure: Maternal Hemodynamic Changes
timeFrame: Assessed every 10 minutes during labor.
measure: Fetal Heart Rate Variations
timeFrame: Recorded every 10 minutes until delivery.
measure: Incidence and Severity of Motor Block
timeFrame: From the first epidural dose until delivery completion (approximately 6 hours on average)
measure: Need for Additional Analgesia
timeFrame: From the first epidural dose until delivery, typically up to 12 hours
measure: Occurrence of Adverse Effects
timeFrame: Monitored at 10-minute intervals throughout labor.
measure: Post-Dural Puncture Headache
timeFrame: up to 1 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.