Epidural vs. Dural Puncture Epidural in Labor Analgesia

NCT06849726 | Completed

• 1 other identifier: Epidural vs DP epidural
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor Pain; Epidural Analgesia

Keywords

Labor Analgesia; Epidural Analgesia; Dural Puncture Epidural

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of Adverse Effects

  Continuously monitored from the initial epidural dose until delivery.

• Requirement for Supplemental Analgesia

  From the initiation of epidural analgesia until delivery.

• Maternal Satisfaction

  Assessed in the early postpartum period.

• Post-Dural Puncture Headache

  Up to 1 week postpartum.

• Incidence and Severity of Motor Block

  Monitored throughout the procedure until delivery.

Study Arms (2)

Standard Epidural Analgesia

ACTIVE COMPARATOR

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

Dural Puncture Epidural (DPE) Analgesia

ACTIVE COMPARATOR

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

Interventions

Dural Puncture Epidural Analgesia 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.

Dural Puncture Epidural (DPE) Analgesia

Standard Epidural Analgesia 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.

Standard Epidural Analgesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ≥ 3-4 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38026464 BACKGROUND

• 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.

  PMID: 32282386 BACKGROUND

• 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.

  PMID: 33545772 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start: March 10, 2025
• Primary Completion: October 20, 2025
• Study Completion: December 20, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)