Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section

January 15, 2026 updated by: Naufal Anasy, Gadjah Mada University

Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial

The goal of this clinical trial is to compare the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing elective cesarean delivery. The study also aims to evaluate hemodynamic stability and procedure-related side effects associated with both techniques.

The main questions it aims to answer are:

  1. What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section?
  2. Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
  3. What procedure-related side effects occur with each anesthetic technique?

Researchers will compare epidural anesthesia with dural puncture epidural (DPE) to determine which technique achieves a faster and more effective sensory block while maintaining maternal hemodynamic stability.

Participants will:

  1. Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
  2. Undergo elective cesarean delivery under regional anesthesia
  3. Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • DI Yogyakarta
      • Sleman, DI Yogyakarta, Indonesia
        • Dr. Sardjito General Hospital
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Persahabatan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women scheduled to undergo cesarean delivery
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Willing to participate in the study by providing written informed consent

Exclusion Criteria:

  • Patients with absolute contraindications to neuraxial anesthesia
  • Patients with known allergy or history of allergy to medications used in the study
  • Patients with psychiatric disorders or who are uncooperative
  • Patients with accidental dural puncture

Dropout Criteria:

  • Patients who require conversion to general anesthesia during the procedure
  • Patients who experience major intraoperative complications (massive hemorrhage, shock, or cardiac arrest)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dural Puncture Epidural (DPE) Anesthesia
Participants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery.
Procedure: Dural Puncture Epidural (DPE) Anesthesia
Dural puncture epidural (DPE) is a combined neuraxial technique that integrates spinal and epidural approaches to enhance the quality of sensory and motor blockade. The procedure begins with dural puncture using a 26-gauge Spinocan spinal needle at the L3-L4 lumbar interspace until cerebrospinal fluid (CSF) is observed, indicating a micro-dural lesion, after which the spinal needle is withdrawn. Subsequently, an epidural catheter is inserted using an 18-gauge Tuohy needle with the loss-of-resistance (LOR) technique using saline, and advanced 4-5 cm into the epidural space. The anesthetic agents administered are the same as those used in conventional epidural anesthesia. This DPE technique is operationalized to accelerate sensory block onset, improve motor block quality, and minimize complications compared with conventional epidural anesthesia.
Active Comparator: Epidural Anesthesia
Participants receive a conventional epidural anesthesia for elective cesarean delivery.
Procedure: epidural anesthesia
Conventional epidural technique for elective cesarean delivery. Epidural anesthesia is a neuraxial technique used for analgesia or anesthesia during cesarean delivery by administering local anesthetic agents through a catheter placed in the epidural space without penetrating the dura mater. In this study, epidural anesthesia is operationalized by inserting an 18-gauge Tuohy needle at the L3-L4 lumbar interspace, advancing the epidural catheter 4-5 cm into the epidural space, followed by administration of 0.5% isobaric bupivacaine combined with 50 µg fentanyl. Parameters recorded include sensory and motor block onset, mean arterial pressure (MAP), heart rate, and procedure- and surgery-related adverse events. In this study, epidural anesthetic dosing is adjusted for patients with very short stature (height <150 cm), with dose reduction based on published literature (10-20%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time (minutes) to achieve bilateral T6 sensory block
Time Frame: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).
Sensory block onset is defined as the time from anesthetic injection until the achievement of sensory block at the T6 dermatome on both the left and right sides. The measurement is recorded in minutes using a stopwatch.
From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).
Time (minutes) to achieve Bromage grade 3 motor block
Time Frame: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)
Motor block onset is defined as the time from anesthetic injection until the achievement of Bromage grade 3 motor block (inability to raise the straight leg). The measurement is recorded in minutes using a stopwatch.
From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure (MAP)
Time Frame: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery
Mean arterial pressure (MAP) is defined as the average arterial blood pressure during a single cardiac cycle and is monitored non-invasively using an automated blood pressure monitor. This parameter is recorded at baseline (minute 0) and subsequently measured every 3 minutes during the first 20 minutes following anesthetic administration.
From baseline (minute 0) to 20 minutes after anesthetic administration during surgery
Heart Rate (HR)
Time Frame: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery
Heart rate is defined as the number of heartbeats per minute and is measured automatically via standard patient monitoring. Heart rate is recorded at baseline (minute 0) and subsequently measured every 3 minutes during the first 20 minutes following anesthetic administration.
From baseline (minute 0) to 20 minutes after anesthetic administration during surgery
Number of participants with Post-dural Puncture Headache (PDPH)
Time Frame: Within 72 hours after neuraxial anesthesia
Post-dural puncture headache (PDPH) is assessed as part of the side effect evaluation. PDPH is defined as a postural headache that worsens when the patient is sitting or standing and improves in the supine position, occurring within 48-72 hours after dural penetration. PDPH is evaluated as a secondary outcome as a potential complication following neuraxial anesthesia, including epidural and dural puncture epidural (DPE) techniques.
Within 72 hours after neuraxial anesthesia
Number of participants with nausea and/or vomiting
Time Frame: During anesthetic administration and surgery
Nausea and vomiting are assessed as part of the side effect evaluation. These outcomes are defined as subjective complaints of nausea and/or observed episodes of vomiting occurring during anesthetic administration and throughout the cesarean delivery procedure. Events are assessed through direct observation and patient self-reporting.
During anesthetic administration and surgery
APGAR Score
Time Frame: At 1 and 5 minutes after birth
APGAR Score is assessed as part of the side effect evaluation. Neonatal outcome is assessed using the Apgar score at 1 and 5 minutes after birth. The Apgar score evaluates five parameters: skin color, heart rate, reflex irritability, muscle tone, and respiration, with a total score ranging from 0 to 10. Apgar scores are recorded by trained healthcare personnel and used as an indicator of immediate neonatal clinical condition.
At 1 and 5 minutes after birth
Number of participants with hypotension
Time Frame: From anesthetic administration until the end of surgery
Hypotension is assessed as part of the side effect evaluation and defined as a decrease in blood pressure of ≥20% from baseline or a mean arterial pressure (MAP) <65 mmHg following neuraxial anesthesia.
From anesthetic administration until the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NaufalRCT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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