NCT07278895

Brief Summary

This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

December 1, 2025

Last Update Submit

January 20, 2026

Conditions

Pregnancy RelatedAnalgesia, EpiduralLabor Pain

Keywords

Dural Puncture EpiduralStandard Epidural AnalgesiaLabor Analgesia

Outcome Measures

Primary Outcomes (1)

  • Time to Onset of Effective Analgesia (VAS < 3)

    Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS \< 3, indicating effective labor analgesia.

    Within 30 minutes after epidural bolus

Secondary Outcomes (11)

  • Sensory Block Level

    Within 30 minutes after epidural bolus

  • Motor Block Score (Bromage Score)

    Within 30 minutes after epidural bolus

  • Need for Additional Epidural Bolus

    During labor until delivery

  • Time to First Additional Bolus

    From initiation of analgesia to delivery

  • Maternal Hemodynamic Changes

    First 30 minutes after epidural bolus

  • +6 more secondary outcomes

Study Arms (2)

Dural Puncture Epidural (DPE)

EXPERIMENTAL

Participants receive Dural Puncture Epidural analgesia using a 27G Whitacre spinal needle inserted through the Tuohy needle before epidural catheter placement, without intrathecal drug administration.

Procedure: Dural Puncture Epidural (DPE)

Standard Epidural Analgesia

ACTIVE COMPARATOR

Participants in this arm receive Standard Epidural Analgesia. The epidural block is performed using a Tuohy needle without dural puncture, and an epidural catheter is inserted into the epidural space. After a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.

Procedure: Standard Epidural Analgesia

Interventions

Dural Puncture Epidural (DPE)PROCEDURE

The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.

Dural Puncture Epidural (DPE)
Standard Epidural AnalgesiaPROCEDURE

Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.

Standard Epidural Analgesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligible participants are exclusively female due to the nature of the study, which involves labor analgesia in term pregnant women.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnant women (≥37 weeks of gestation).
  • Requesting neuraxial labor analgesia.
  • Age between 18 and 45 years.
  • ASA physical status I-II.
  • Cervical dilation ≥ 4 cm at the time of enrollment.
  • Cervical effacement ≥ 50-60%.
  • Baseline pain score of VAS ≥ 3.
  • Ability to provide informed consent.

You may not qualify if:

  • Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
  • Placental abnormalities (placenta previa, placental abruption, etc.).
  • Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
  • Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
  • Morbid obesity (Body Mass Index ≥ 40 kg/m²).
  • Opioid dependence or chronic opioid use.
  • Accidental dural puncture with the epidural needle prior to randomization.
  • Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
  • Fetal distress at the time of enrollment.
  • Patient refusal to participate.
  • Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Pazur I, Ozegic O, Lijovic L, Jaic KK, Pesic M. The Efficacy of Dural Puncture Epidural Performed by 27-gauge Whitacre Needle in Labour Epidural Analgesia: Randomized Single-Blinded Controlled Study. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):304-310. doi: 10.4274/TJAR.2023.221085.

    PMID: 37587657BACKGROUND

MeSH Terms

Conditions

AgnosiaLabor Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Central Study Contacts

Mehmet Baran, MD

CONTACT

+905349218969mehmetbaran1492@gmail.com

Mustafa Bıçak, MD

CONTACT

+905320571437drmustafabicak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Due to the nature of the neuraxial procedures, the anesthesiologist performing the block cannot be blinded to the intervention. Participants and clinical staff are also aware of the assigned technique. No masking was applied.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a two-arm parallel assignment model in which eligible laboring women are randomized equally to receive either Dural Puncture Epidural (DPE) analgesia or Standard Epidural Analgesia. Both groups are managed and observed concurrently without crossover between interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

January 20, 2026

Primary Completion

March 23, 2026

Study Completion

March 30, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request. Data will be provided via email after review and approval of the research proposal by the principal investigator.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available starting 6 months after publication of the study results and will remain available for up to 5 years.
Access Criteria
De-identified IPD will be shared via email upon reasonable request and PI approval. e-mail:mehmetbaran1492@gmail.com

Locations

TU(1)