Epidural vs. Dural Puncture Epidural in Labor Analgesia

Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia

Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Labor Pain
• Intervention / Treatment: Procedure: Standard Epidural Analgesia; Procedure: Dural Puncture Epidural Analgesia

Detailed Description

The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS < 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction. Note on outcome reporting: serial intrapartum measurements of maternal blood pressure, maternal heart rate and fetal heart rate were not documented on the routine anesthesia monitoring forms used during the retrospective control period. The registered secondary outcome of maternal hemodynamic and fetal heart rate variation could therefore not be compared between the two cohorts. Baseline values recorded before the procedure were available for all 100 participants and are reported as baseline characteristics, together with the incidence of hypotension and of fetal bradycardia. No registered outcome has been removed from this record.

• Study Type: Observational
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy pregnant women (ASA physical status I-II) with a singleton pregnancy at 37-42 weeks of gestation, who planned a vaginal delivery and requested labor analgesia during active labor (cervical dilation ≥ 4 cm) at a single university hospital.

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-II
• Gestational age 37-42 weeks
• Planned vaginal delivery
• Request for labor analgesia during active labor with cervical dilation ≥ 4 cm

Exclusion Criteria:

• Multiple gestations
• Diagnosis of preeclampsia/eclampsia
• Severe systemic disease
• Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site)
• History of opioid dependence
• Refusal to participate in the study protocol
• Missing data in medical records for the retrospective group

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Epidural Analgesia; Patients in this retrospective control group received the standard concentration epidural analgesia. Using an 18-G Tuohy needle, the epidural space was identified and a catheter was advanced. No dural puncture was performed. A loading dose consisting of 0.125% bupivacaine (25 mg) and fentanyl (40 µg) in a total volume of 20 mL was administered via the catheter.	Procedure: 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.
Dural Puncture Epidural (DPE) Analgesia; Patients in this prospective intervention group received the low-dose DPE technique. After identifying the epidural space, the dura mater was punctured using a 27-G spinal needle until the clear return of cerebrospinal fluid was visualized. No intrathecal medication was administered, the spinal needle was withdrawn, and the epidural catheter was positioned. A loading dose consisting of 0.0625% bupivacaine (12.5 mg) and fentanyl (40 µg) in a total volume of 20 mL was applied.	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 administration of a lower concentration of bupivacaine with the same dose of fentanyl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Analgesic Consumption	Cumulative bupivacaine consumption measured in milligrams.	From the initiation of epidural analgesia until delivery.
Adequate Analgesia Achievement	Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4	Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Effects	Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia	Continuously monitored from the initial epidural dose until delivery.
Requirement for Supplemental Analgesia	Total number of supplemental boluses required during labor	From the initiation of epidural analgesia until delivery.
Maternal Satisfaction	Documented patient satisfaction levels regarding the childbirth experience	Assessed in the early postpartum period.
Post-Dural Puncture Headache	Incidence and severity of post-dural puncture headache in the postpartum period.	Up to 1 week postpartum.
Incidence and Severity of Motor Block	Occurrence and degree of motor block, evaluated by the Modified Bromage Scale.	Monitored throughout the procedure until delivery.
Maternal Hemodynamic and Fetal Heart Rate Variations	Variation in maternal blood pressure, heart rate, and fetal heart rate changes.	Continuously monitored throughout the procedure.

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Burak öMÜR, Medipol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Epidural Analgesia; Labor Analgesia; Dural Puncture Epidural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain
• Other Study ID Numbers: Epidural vs DP epidural

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication
• IPD Sharing Time Frame: Beginning 6 months after publication of the results article and ending 5 years after publication.
• IPD Sharing Access Criteria: Requests should be directed to the corresponding author (bomur@medipol.edu.tr). De-identified individual participant data underlying the published results will be shared with investigators who provide a methodologically sound proposal, at the discretion of the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No